Trial Outcomes & Findings for Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits (NCT NCT00487942)

Results Overview

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represents the change from baseline to last observation after baseline in Composite T-Score.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Baseline and 4 weeks (or last observation after Baseline)

Results posted on

2013-07-19

Participant Flow

Eleven centers in the United States (US). First participant enrolled: July 2007 / Last participant last visit: December 2007

The study consisted of a screening period of at least 1 week, a 4 week double blind treatment period, and a 1 week follow up period. Of the 60 patients enrolled, 59 patients received at least 1 dose of study drug and were evaluated for safety; 1 patient who was assigned to receive placebo withdrew before taking any study drug.

Participant milestones

Participant milestones
Measure	Armodafinil 50 mg/Day Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Overall Study STARTED	15	15	15	15
Overall Study COMPLETED	12	12	12	13
Overall Study NOT COMPLETED	3	3	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Armodafinil 50 mg/Day Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Overall Study Adverse Event	1	1	1	1
Overall Study Lost to Follow-up	1	0	0	1
Overall Study Protocol Violation	1	1	0	0
Overall Study Withdrawal by Subject	0	1	2	0

Baseline Characteristics

Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodafinil 50 mg/Day n=15 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=15 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=15 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=15 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	60 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age Continuous	44.9 years STANDARD_DEVIATION 10.88 • n=5 Participants	40.4 years STANDARD_DEVIATION 9.58 • n=7 Participants	41.4 years STANDARD_DEVIATION 9.78 • n=5 Participants	46.0 years STANDARD_DEVIATION 7.80 • n=4 Participants	43.2 years STANDARD_DEVIATION 9.62 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	16 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	44 Participants n=21 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	15 participants n=5 Participants	15 participants n=4 Participants	60 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represents the change from baseline to last observation after baseline in Composite T-Score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	1.9 Units on a scale Standard Deviation 6.22	2.8 Units on a scale Standard Deviation 7.98	2.9 Units on a scale Standard Deviation 4.72	2.2 Units on a scale Standard Deviation 5.06

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had a MATRICS efficacy assessment at baseline and at Week 4. If any part of the composite score was missing then the composite score was set to missing. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in composite T-score from baseline to 4 weeks.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score	2.2 Units on a scale Standard Deviation 6.13	3.9 Units on a scale Standard Deviation 5.99	2.9 Units on a scale Standard Deviation 4.72	2.1 Units on a scale Standard Deviation 5.28

SECONDARY outcome

Timeframe: Baseline 4 weeks (or last observation after baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Processing Speed Domain T-score from baseline to last observation after baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	3.0 Units on a scale Standard Deviation 8.81	0.0 Units on a scale Standard Deviation 10.42	5.0 Units on a scale Standard Deviation 9.14	0.9 Units on a scale Standard Deviation 6.95

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Attention/Vigilance Domain T-score from baseline to last observation after baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Attention/Vigilance Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	0.4 Units on a scale Standard Deviation 10.89	3.7 Units on a scale Standard Deviation 5.02	1.8 Units on a scale Standard Deviation 6.51	3.0 Units on a scale Standard Deviation 6.56

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Working Memory Domain T-score from baseline to last observation after baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Working Memory Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	2.3 Units on a scale Standard Deviation 6.51	4.3 Units on a scale Standard Deviation 6.02	3.5 Units on a scale Standard Deviation 10.41	4.4 Units on a scale Standard Deviation 6.33

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Verbal Learning Domain T-score from baseline to last observation after baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Verbal Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	-1.2 Units on a scale Standard Deviation 6.31	-0.8 Units on a scale Standard Deviation 4.49	0.8 Units on a scale Standard Deviation 6.31	-2.2 Units on a scale Standard Deviation 5.93

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, where the mean is 50 and a standard deviation is 10 for the composite. The data here represent the mean change in Visual Learning Domain T-score from baseline to last observation after baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Visual Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	4.3 Units on a scale Standard Deviation 9.55	3.9 Units on a scale Standard Deviation 12.84	1.3 Units on a scale Standard Deviation 8.76	0.2 Units on a scale Standard Deviation 8.15

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument containing 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Reasoning and Problem Solving Domain T-score from baseline to last observation after baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Reasoning and Problem Solving Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	1.6 Units on a scale Standard Deviation 4.31	-0.4 Units on a scale Standard Deviation 5.60	-0.3 Units on a scale Standard Deviation 8.36	-0.2 Units on a scale Standard Deviation 4.63

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Domain score combines the individual test scores of the Domain and scores them on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10) for the composite. The data here represent the mean change in Social Cognition Domain T-score from baseline to last observation after baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Social Cognition Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	-3.1 Units on a scale Standard Deviation 6.93	-1.3 Units on a scale Standard Deviation 8.20	3.6 Units on a scale Standard Deviation 8.26	3.8 Units on a scale Standard Deviation 6.62

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Trail Making Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Trail Making Test T-score from baseline to last observation after baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Trail Making Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	4.2 Units on a scale Standard Deviation 13.15	-0.2 Units on a scale Standard Deviation 11.76	9.2 Units on a scale Standard Deviation 15.43	-1.0 Units on a scale Standard Deviation 7.80

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The BASC SC Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in BASC SC Test T-score from baseline to last observation after baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BASC SC) Test of the MATRICS Consensus Cognitive Battery	0.6 Units on a scale Standard Deviation 9.14	-0.4 Units on a scale Standard Deviation 11.26	2.4 Units on a scale Standard Deviation 7.93	4.0 Units on a scale Standard Deviation 7.25

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The Fluency Test is a component of the Speed of Processing Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in Fluency Test T-score from baseline to last observation after baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Fluency Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	2.2 Units on a scale Standard Deviation 7.81	0.8 Units on a scale Standard Deviation 7.83	-0.5 Units on a scale Standard Deviation 4.68	-1.4 Units on a scale Standard Deviation 7.12

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The WMS-III SS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in WMS-III SS T-score from baseline to last observation after baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Wechsler Memory Scale: Spatial Span (WMS-III SS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	0.7 Units on a scale Standard Deviation 8.47	4.7 Units on a scale Standard Deviation 7.21	2.9 Units on a scale Standard Deviation 8.08	2.5 Units on a scale Standard Deviation 5.67

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 MATRICS efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The LNS is a component of the Working Memory Domain scored on a normative scale to derive a T-score, (mean is 50 and standard deviation is 10). The data here represent the mean change in LNS T-score from baseline to last observation after baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Letter-Number Span (LNS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery	3.1 Units on a scale Standard Deviation 6.32	2.1 Units on a scale Standard Deviation 6.16	3.1 Units on a scale Standard Deviation 9.63	4.5 Units on a scale Standard Deviation 6.79

SECONDARY outcome

Timeframe: 4 weeks (or last observation after baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only "right" or "wrong" to each placement. Examiner may change matching rules during the test. Perseveration errors occur when subject repeats the same error no matter how many times they are told the placement is wrong. The change from baseline in number of perseveration errors was assessed.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Number of Perseverative Errors	1.6 Errors Standard Deviation 5.35	-8.0 Errors Standard Deviation 12.79	-2.2 Errors Standard Deviation 11.75	-1.9 Errors Standard Deviation 7.77

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only "right" or "wrong" to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of consecutive responses on the final category was assessed.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Consecutive Responses on the Final Category	-1.6 Responses Standard Deviation 2.98	-0.5 Responses Standard Deviation 4.46	0.3 Responses Standard Deviation 2.64	0.7 Responses Standard Deviation 3.80

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

WCST is an instrument administered electronically to assess abstract reasoning and ability to alter problem solving strategies. Patients are given 64 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only "right" or "wrong" to each placement. Examiner may change matching rules (sorting categories) during the test at which time the subject must alter their sorting category. The change from baseline in number of sorting categories achieved was assessed.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Categories Completed	0.0 Categories Completed Standard Deviation 1.36	0.5 Categories Completed Standard Deviation 1.85	-0.3 Categories Completed Standard Deviation 1.66	0.2 Categories Completed Standard Deviation 0.72

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

Trail B is an instrument designed to assess set shifting. The patient was given a paper with numbers and letters on it and asked to connect them in an alternating manner (eg. 1-A-2-B-3C). The time required for the patient to complete the test was recorded. The change from Baseline to last observation following Baseline in the time necessary to complete the test is presented here.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Trails B Test	-8.7 Minutes Standard Deviation 41.45	17.5 Minutes Standard Deviation 56.31	-20.8 Minutes Standard Deviation 61.93	-27.6 Minutes Standard Deviation 40.92

SECONDARY outcome

Timeframe: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who had a baseline and at least one post-baseline assessment by actigraphy

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch).

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Average Activity	-17.6 Counts Standard Deviation 25.81	-0.7 Counts Standard Deviation 27.33	4.2 Counts Standard Deviation 27.77	0.8 Counts Standard Deviation 32.98

SECONDARY outcome

Timeframe: Baseline and Week 1

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch)to Week 1.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Average Activity	-2.3 Counts Standard Deviation 43.02	8.9 Counts Standard Deviation 38.10	2.1 Counts Standard Deviation 31.05	0.8 Counts Standard Deviation 36.66

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 2.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Average Activity	-15.4 Counts Standard Deviation 27.93	-7.9 Counts Standard Deviation 38.40	-7.2 Counts Standard Deviation 30.97	13.1 Counts Standard Deviation 40.32

SECONDARY outcome

Timeframe: Baseline and Week 3

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 3.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Average Activity	1.5 Counts Standard Deviation 38.40	7.2 Counts Standard Deviation 29.11	9.9 Counts Standard Deviation 35.90	-1.6 Counts Standard Deviation 25.68

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in average activity per epoch (counts/epoch) to Week 4.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=8 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Average Activity	-15.4 Counts Standard Deviation 27.06	9.0 Counts Standard Deviation 34.81	-0.4 Counts Standard Deviation 39.18	-18.7 Counts Standard Deviation 39.70

SECONDARY outcome

Timeframe: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline in maximum activity to Endpoint.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Maximum Activity	-124.3 Counts Standard Deviation 235.16	-73.2 Counts Standard Deviation 284.32	70.4 Counts Standard Deviation 191.11	-5.9 Counts Standard Deviation 267.21

SECONDARY outcome

Timeframe: Baseline and Week 1

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in maximum activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Maximum Activity	-85.7 Counts Standard Deviation 312.58	14.8 Counts Standard Deviation 365.46	20.5 Counts Standard Deviation 436.62	6.2 Counts Standard Deviation 309.81

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in maximum activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Maximum Activity	-152.7 Counts Standard Deviation 244.27	-146.3 Counts Standard Deviation 291.42	11.8 Counts Standard Deviation 282.99	-28.4 Counts Standard Deviation 288.45

SECONDARY outcome

Timeframe: Baseline and Week 3

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in maximum activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Maximum Activity	1420.4 Counts Standard Deviation 345.81	1522.5 Counts Standard Deviation 558.66	1469.2 Counts Standard Deviation 440.96	1505.1 Counts Standard Deviation 356.41

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in maximum activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=8 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Maximum Activity	-173.5 Counts Standard Deviation 371.31	-61.4 Counts Standard Deviation 335.30	57.5 Counts Standard Deviation 218.02	-60.4 Counts Standard Deviation 286.13

SECONDARY outcome

Timeframe: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to endpoint in standard deviation of activity (counts/epoch).

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Standard Deviation of Activity	-5.1 Counts Standard Deviation 17.97	-0.7 Counts Standard Deviation 25.68	6.0 Counts Standard Deviation 17.04	-1.9 Counts Standard Deviation 20.07

SECONDARY outcome

Timeframe: Baseline and Week 1

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in standard deviation of activity (counts/epoch).

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Standard Deviation of Activity	-4.3 Counts Standard Deviation 20.75	7.6 Counts Standard Deviation 27.14	4.2 Counts Standard Deviation 23.35	1.7 Counts Standard Deviation 32.05

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in standard deviation of activity (counts/epoch).

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Standard Deviation of Activity	-11.3 Counts Standard Deviation 23.14	-6.6 Counts Standard Deviation 31.61	-6.6 Counts Standard Deviation 21.20	-0.3 Counts Standard Deviation 24.53

SECONDARY outcome

Timeframe: Baseline and Week 3

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in standard deviation of activity (counts/epoch).

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Standard Deviation of Activity	5.2 Counts Standard Deviation 32.29	-6.6 Counts Standard Deviation 29.58	15.2 Counts Standard Deviation 26.98	1.1 Counts Standard Deviation 26.70

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in standard deviation of activity (counts/epoch).

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=8 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Standard Deviation of Activity	-7.9 Counts Standard Deviation 26.27	6.3 Counts Standard Deviation 30.62	7.4 Counts Standard Deviation 40.16	-7.6 Counts Standard Deviation 23.50

SECONDARY outcome

Timeframe: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Total Activity	7037.0 Counts Standard Deviation 63882.86	-9164.8 Counts Standard Deviation 75454.69	23631.1 Counts Standard Deviation 70519.50	-24811.4 Counts Standard Deviation 95900.22

SECONDARY outcome

Timeframe: Baseline and Week 1

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Total Activity	5913.6 Counts Standard Deviation 63868.75	-3818.5 Counts Standard Deviation 78107.11	23665.1 Counts Standard Deviation 83030.07	-12675.4 Counts Standard Deviation 118072.5

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Total Activity	2346.8 Counts Standard Deviation 45862.44	-32082.8 Counts Standard Deviation 91836.83	3103.1 Counts Standard Deviation 69263.03	30660.0 Counts Standard Deviation 111626.4

SECONDARY outcome

Timeframe: Baseline and Week 3

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Total Activity	39831.8 Counts Standard Deviation 115073.2	16850.4 Counts Standard Deviation 55047.52	56889.1 Counts Standard Deviation 83338.41	29067.5 Counts Standard Deviation 178423.5

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=8 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Total Activity	1341.8 Counts Standard Deviation 92122.95	12620.9 Counts Standard Deviation 88874.07	55151.0 Counts Standard Deviation 67614.02	-24323.9 Counts Standard Deviation 104375.7

SECONDARY outcome

Timeframe: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Minimum Value for Actigraphy Data of Total Activity	-41210.0 Counts Standard Deviation 97542.44	-16150.5 Counts Standard Deviation 45645.34	-5159.5 Counts Standard Deviation 25855.48	-34443.8 Counts Standard Deviation 72427.27

SECONDARY outcome

Timeframe: Baseline and Week 1

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 1 in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in the Minimum Value for Actigraphy Data of Total Activity	2419.5 Counts Standard Deviation 147029.2	37665.8 Counts Standard Deviation 124537.9	15892.7 Counts Standard Deviation 36649.79	1116.3 Counts Standard Deviation 100205.7

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Minimum Value for Actigraphy Data of Total Activity	-3534.2 Counts Standard Deviation 45509.04	27543.3 Counts Standard Deviation 89272.51	7937.0 Counts Standard Deviation 19889.36	27759.5 Counts Standard Deviation 100774.8

SECONDARY outcome

Timeframe: Baseline and Week 3

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 3 in the Minimum Value for Actigraphy Data of Total Activity	89886.7 Counts Standard Deviation 58766.65	91057.2 Counts Standard Deviation 105129.3	126496.5 Counts Standard Deviation 71256.20	60259.0 Counts Standard Deviation 81898.19

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 4 in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=8 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Minimum Value for Actigraphy Data of Total Activity	-12493.6 Counts Standard Deviation 40759.54	-6742.8 Counts Standard Deviation 45841.91	39458.0 Counts Standard Deviation 36820.07	1744.3 Counts Standard Deviation 92667.31

SECONDARY outcome

Timeframe: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who had at least one assessment by actigraphy after baseline

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Endpoint in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Maximum Value for Actigraphy Data of Total Activity	175906.8 Counts Standard Deviation 234098.9	45621.4 Counts Standard Deviation 112402.4	144855.3 Counts Standard Deviation 191836.4	38708.1 Counts Standard Deviation 132339.4

SECONDARY outcome

Timeframe: Baseline and Week 1

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 1

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to week 1 in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in the Maximum Value for Actigraphy Data of Total Activity	92077.4 Counts Standard Deviation 260737.6	-28961.9 Counts Standard Deviation 96313.45	18639.8 Counts Standard Deviation 95180.94	-118038 Counts Standard Deviation 388177.5

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 2

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 2 in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Maximum Value for Actigraphy Data of Total Activity	-46326.7 Counts Standard Deviation 105330.1	-44034.8 Counts Standard Deviation 120738.2	-1954.7 Counts Standard Deviation 97046.14	-78154.5 Counts Standard Deviation 367148.4

SECONDARY outcome

Timeframe: Baseline and Week 3

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 3

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 3 in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 3 in the Maximum Value for Actigraphy Data of Total Activity	40120.5 Counts Standard Deviation 151218.3	23748.0 Counts Standard Deviation 107713.9	61304.7 Counts Standard Deviation 158096.3	-41751.7 Counts Standard Deviation 117072.2

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: Full analysis set defined as subjects who had an assessment by actigraphy at baseline and at Week 4

An actigraphy device was worn by each patient starting with the initial screening. The device continuously measured movement, allowing for an evaluation of spontaneous motor activity. Data from the actigraphy device were downloaded at each visit. The data presented here is the change from baseline to Week 4 in total activity.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=8 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Maximum Value for Actigraphy Data of Total Activity	7898.0 Counts Standard Deviation 71370.81	-10300.1 Counts Standard Deviation 165816.5	123442.9 Counts Standard Deviation 168028.8	-240840 Counts Standard Deviation 666800.6

SECONDARY outcome

Timeframe: Baseline and Week 4 or last observation after baseline

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had at least 1 efficacy assessment after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores	-3.9 Units on a scale Standard Deviation 7.87	-0.7 Units on a scale Standard Deviation 8.22	-4.6 Units on a scale Standard Deviation 6.19	-3.1 Units on a scale Standard Deviation 4.28

SECONDARY outcome

Timeframe: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=9 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=10 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores	-5.0 Units on a scale Standard Deviation 5.63	-3.0 Units on a scale Standard Deviation 6.88	-1.6 Units on a scale Standard Deviation 3.17	-3.3 Units on a scale Standard Deviation 4.16

SECONDARY outcome

Timeframe: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who had an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=9 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=10 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=9 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores	-3.8 Units on a scale Standard Deviation 8.33	-1.8 Units on a scale Standard Deviation 8.90	-4.6 Units on a scale Standard Deviation 6.19	-2.6 Units on a scale Standard Deviation 4.16

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at least once after baseline. Summary statistics are provided for the observed data only, missing data was not estimated.

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating	0.3 Units on a scale Standard Deviation 1.86	-0.2 Units on a scale Standard Deviation 1.37	-0.3 Units on a scale Standard Deviation 1.50	-0.4 Units on a scale Standard Deviation 1.73

SECONDARY outcome

Timeframe: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

n The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating	0.0 Units on a scale Standard Deviation 1.86	-0.3 Units on a scale Standard Deviation 0.98	0.6 Units on a scale Standard Deviation 2.02	-0.8 Units on a scale Standard Deviation 1.71

SECONDARY outcome

Timeframe: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose interviewers completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The SCoRS is an 18-item interview based assessment covering all the cognitive domains in the MATRICS Consensus Cognitive Battery except social cognition. It is administered separately to the patient and an informant (family or friend) who are asked to rate the patient's level of difficulty in performing various cognitive functions on a 4-point scale (higher rating = greater impairment). They also complete a global assessment of cognitive function on a 1-10 scale. The interviewer factors in their own assessment on both the 18-items (Total Score) and the global assessment for the final score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating	-0.1 Units on a scale Standard Error 1.45	-0.4 Units on a scale Standard Error 1.38	-0.3 Units on a scale Standard Error 1.50	-0.5 Units on a scale Standard Error 1.78

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as the number of subjects who had at least one observation after baseline

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Endpoint which is Week 4 or the last observation following Baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline Normal	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline Borderline ill	0 Participants	1 Participants	1 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline Mildly ill	11 Participants	8 Participants	10 Participants	11 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline Moderately ill	3 Participants	5 Participants	1 Participants	2 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline Severely ill	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline Among the most extremely ill	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline Markedly ill	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 4 or last observation following Baseline

Population: Full analysis set defined as subjects who have at least one observation after Baseline

The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 or at the last observation following Baseline is presented.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline Very much improved	1 Participants	2 Participants	4 Participants	3 Participants
Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline Much improved	3 Participants	2 Participants	1 Participants	2 Participants
Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline Minimally improved	9 Participants	4 Participants	6 Participants	5 Participants
Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline Minimally worse	0 Participants	1 Participants	1 Participants	1 Participants
Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline Much worse	1 Participants	0 Participants	0 Participants	0 Participants
Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline Very much worse	0 Participants	0 Participants	0 Participants	0 Participants
Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline No change	0 Participants	5 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline

SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Endpoint.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in Scale for the Assessment of Negative Symptoms (SANS) Total Scores	-5.6 Units on a scale Standard Deviation 11.78	-3.0 Units on a scale Standard Deviation 9.77	-7.4 Units on a scale Standard Deviation 14.23	-6.1 Units on a scale Standard Deviation 9.78

SECONDARY outcome

Timeframe: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 1.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores	-1.4 Units on a scale Standard Deviation 4.11	-2.5 Units on a scale Standard Deviation 7.62	-2.2 Units on a scale Standard Deviation 13.11	-2.2 Units on a scale Standard Deviation 6.73

SECONDARY outcome

Timeframe: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 2.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores	0.4 Units on a scale Standard Deviation 10.13	-4.5 Units on a scale Standard Deviation 12.08	-4.4 Units on a scale Standard Deviation 13.87	-6.8 Units on a scale Standard Deviation 12.11

SECONDARY outcome

Timeframe: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

SANS is a clinician-rated instrument that rates the severity of negative symptoms of schizophrenia. It contains 25 items in 5 domains: affective flattening/blunting, alogia, avolition-apathy, anhedonia-asociality, attentional impairment. Items in a domain assess symptoms and a global item assesses the overall severity of the domain. Each item is scored on a 6-point severity scale(0=Not at all, 1=questionable decrease, 2=mild, 3=moderate, 4=marked, 5=severe). The total scale ranges from 0-125. Data presented here represents change in total score from Baseline to Week 4.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores	-5.3 Units on a scale Standard Deviation 12.73	-5.6 Units on a scale Standard Deviation 6.97	-7.4 Units on a scale Standard Deviation 14.23	-6.3 Units on a scale Standard Deviation 10.17

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Endpoint.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score	-0.3 Units on a scale Standard Deviation 4.03	-0.3 Units on a scale Standard Deviation 3.43	-3.4 Units on a scale Standard Deviation 2.07	0.1 Units on a scale Standard Deviation 1.93

SECONDARY outcome

Timeframe: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 1.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score	0.4 Units on a scale Standard Deviation 2.71	-0.1 Units on a scale Standard Deviation 3.28	-2.5 Units on a scale Standard Deviation 1.97	-0.4 Units on a scale Standard Deviation 2.60

SECONDARY outcome

Timeframe: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 2.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score	-0.1 Units on a scale Standard Deviation 3.18	-1.4 Units on a scale Standard Deviation 2.61	-2.3 Units on a scale Standard Deviation 2.05	-0.8 Units on a scale Standard Deviation 1.82

SECONDARY outcome

Timeframe: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Negative Scale score ranges from 7 to 49. The data here represents the change in Negative Rating Scale from Baseline to Week 4.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score	-0.1 Units on a scale Standard Deviation 4.29	-1.3 Units on a scale Standard Deviation 2.38	-3.4 Units on a scale Standard Deviation 2.07	0.0 Units on a scale Standard Deviation 2.00

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Endpoint.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation Following Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score	-2.5 Units on a scale Standard Deviation 8.56	-0.9 Units on a scale Standard Deviation 7.77	-6.3 Units on a scale Standard Deviation 7.25	-1.7 Units on a scale Standard Deviation 4.89

SECONDARY outcome

Timeframe: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 1.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score	0.5 Units on a scale Standard Deviation 4.97	-0.8 Units on a scale Standard Deviation 4.82	-4.0 Units on a scale Standard Deviation 4.86	-2.3 Units on a scale Standard Deviation 5.92

SECONDARY outcome

Timeframe: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 2.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score	-2.1 Units on a scale Standard Deviation 7.05	-3.2 Units on a scale Standard Deviation 5.15	-3.0 Units on a scale Standard Deviation 7.08	-2.8 Units on a scale Standard Deviation 4.32

SECONDARY outcome

Timeframe: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Total score ranges from 7 to 210. The data here represents the change in Total score from Baseline to Week 4.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score	-2.1 Units on a scale Standard Deviation 7.39	-3.1 Units on a scale Standard Deviation 5.85	-6.3 Units on a scale Standard Deviation 7.25	-2.1 Units on a scale Standard Deviation 4.89

SECONDARY outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Full analysis set defined as the number of subjects who had at least one baseline observation and one observation after baseline

ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Endpoint (Week 4 or last observation following baseline) in the ESS total score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation Following Baseline in Epworth Sleepiness Scale (ESS) Total Scores	-2.1 Units on a scale Standard Deviation 4.87	-0.6 Units on a scale Standard Deviation 5.36	1.0 Units on a scale Standard Deviation 4.43	-0.5 Units on a scale Standard Deviation 7.48

SECONDARY outcome

Timeframe: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 1 in the ESS total score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in Epworth Sleepiness Scale (ESS) Total Scores	-2.2 Units on a scale Standard Deviation 5.39	-1.4 Units on a scale Standard Deviation 6.05	0.0 Units on a scale Standard Deviation 2.65	-1.5 Units on a scale Standard Deviation 6.16

SECONDARY outcome

Timeframe: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 2 in the ESS total score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in Epworth Sleepiness Scale (ESS) Total Scores	-1.1 Units on a scale Standard Deviation 6.27	-1.6 Units on a scale Standard Deviation 6.33	0.3 Units on a scale Standard Deviation 3.14	-2.1 Units on a scale Standard Deviation 6.68

SECONDARY outcome

Timeframe: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

ESS is a self-administered subjective measure of daytime sleepiness, based on responses to questions referring to 8 everyday situations (eg. sitting and reading, talking to someone) and reflects a patient's propensity to fall asleep in those situations. Score for the ESS range from 0 to 24 with higher scores indicating greater daytime sleepiness. Data here represents the change from Baseline to Week 4 in the ESS total score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in Epworth Sleepiness Scale (ESS) Total Scores	-2.0 Units on a scale Standard Deviation 5.29	-0.5 Units on a scale Standard Deviation 5.78	1.0 Units on a scale Standard Deviation 4.43	-1.7 Units on a scale Standard Deviation 6.36

SECONDARY outcome

Timeframe: Baseline and 1 week

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 1.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1 Normal	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1 Markedly ill	1 Participants	0 Participants	0 Participants	1 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1 Severely ill	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1 Borderline ill	0 Participants	0 Participants	1 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1 Mildly ill	10 Participants	11 Participants	8 Participants	11 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1 Moderately ill	3 Participants	2 Participants	2 Participants	1 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1 Among the most extremely ill	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and 2 weeks

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 2.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2 Borderline ill	0 Participants	1 Participants	1 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2 Moderately ill	3 Participants	3 Participants	1 Participants	1 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2 Markedly ill	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2 Severely ill	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2 Among the most extremely ill	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2 Normal	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2 Mildly ill	9 Participants	8 Participants	10 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at week 4.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 Normal	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 Borderline ill	0 Participants	1 Participants	1 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 Moderately ill	2 Participants	3 Participants	1 Participants	1 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 Severely ill	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 Mildly ill	10 Participants	8 Participants	10 Participants	11 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 Markedly ill	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 Among the most extremely ill	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 1

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 1 is presented here.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=11 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Patient Global Impression of Change (PGIC) at Week 1 Minimally improved	2 Participants	0 Participants	6 Participants	4 Participants
Patient Global Impression of Change (PGIC) at Week 1 Very much worse	0 Participants	0 Participants	0 Participants	0 Participants
Patient Global Impression of Change (PGIC) at Week 1 Very much improved	1 Participants	2 Participants	2 Participants	1 Participants
Patient Global Impression of Change (PGIC) at Week 1 Much improved	1 Participants	1 Participants	1 Participants	3 Participants
Patient Global Impression of Change (PGIC) at Week 1 No change	9 Participants	10 Participants	2 Participants	4 Participants
Patient Global Impression of Change (PGIC) at Week 1 Minimally worse	0 Participants	0 Participants	0 Participants	1 Participants
Patient Global Impression of Change (PGIC) at Week 1 Much worse	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 2

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 2 is presented here.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Patient Global Impression of Change (PGIC) at Week 2 Very much improved	1 Participants	2 Participants	2 Participants	3 Participants
Patient Global Impression of Change (PGIC) at Week 2 Much improved	3 Participants	1 Participants	3 Participants	4 Participants
Patient Global Impression of Change (PGIC) at Week 2 Minimally improved	2 Participants	3 Participants	5 Participants	2 Participants
Patient Global Impression of Change (PGIC) at Week 2 No change	5 Participants	6 Participants	2 Participants	3 Participants
Patient Global Impression of Change (PGIC) at Week 2 Minimally worse	1 Participants	0 Participants	0 Participants	0 Participants
Patient Global Impression of Change (PGIC) at Week 2 Much worse	0 Participants	0 Participants	0 Participants	0 Participants
Patient Global Impression of Change (PGIC) at Week 2 Very much worse	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 4

Population: Full analysis set defined as subjects who received one or more doses of the study drug and who completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The PGIC is a patient-rated scale of the change in disease severity. The PGIC uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. The number of subjects who rated each category at Week 4 is presented here.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=12 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Patient Global Impression of Change (PGIC) at Week 4 Very much improved	1 Participants	2 Participants	4 Participants	3 Participants
Patient Global Impression of Change (PGIC) at Week 4 Much improved	3 Participants	2 Participants	1 Participants	2 Participants
Patient Global Impression of Change (PGIC) at Week 4 Minimally improved	7 Participants	4 Participants	6 Participants	5 Participants
Patient Global Impression of Change (PGIC) at Week 4 No change	0 Participants	4 Participants	0 Participants	1 Participants
Patient Global Impression of Change (PGIC) at Week 4 Minimally worse	0 Participants	0 Participants	1 Participants	1 Participants
Patient Global Impression of Change (PGIC) at Week 4 Much worse	1 Participants	0 Participants	0 Participants	0 Participants
Patient Global Impression of Change (PGIC) at Week 4 Very much worse	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set defined as the number of subjects who had at least one observation after baseline

The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The CGI-S was assessed at Baseline, Week 1, Week 2 and Week 4. Data is presented representing the number of subjects who rated each CGI-S score at Baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline Normal	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline Mildly ill	10 Participants	11 Participants	8 Participants	11 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline Markedly ill	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline Borderline ill	0 Participants	0 Participants	1 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline Moderately ill	4 Participants	3 Participants	3 Participants	2 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline Severely ill	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline Among the most extremely ill	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline

The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=15 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=14 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Modified Simpson-Angus Scale Total Score	0.1 Units on a scale Standard Deviation 0.46	-0.1 Units on a scale Standard Deviation 1.33	-0.3 Units on a scale Standard Deviation 0.83	0.3 Units on a scale Standard Deviation 0.61

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 1.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=15 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=14 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in the Modified Simpson-Angus Scale Total Score	0.0 Units on a scale Standard Deviation 0.38	-0.2 Units on a scale Standard Deviation 0.38	-0.1 Units on a scale Standard Deviation 1.00	-0.1 Units on a scale Standard Deviation 0.47

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 2.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Modified Simpson-Angus Scale Total Score	0.1 Units on a scale Standard Deviation 0.28	-0.4 Units on a scale Standard Deviation 2.23	-0.3 Units on a scale Standard Deviation 1.14	0.0 Units on a scale Standard Deviation 0.41

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The Modified Simpson Angus Scale is a clinician-rated scale to assess the presence and severity of extrapyramidal symptoms associated study drug treatment. This is a 10-item scale that focuses on rigidity. The items are rated using a 5-point (0 - 4) scale. The total score ranges between 0 and 40. The data presented here represents the change from Baseline to Week 4.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Modified Simpson-Angus Scale Total Score	-0.1 Units on a scale Standard Deviation 0.29	-0.1 Units on a scale Standard Deviation 1.44	-0.2 Units on a scale Standard Deviation 0.72	0.2 Units on a scale Standard Deviation 0.60

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.

The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=15 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=14 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation Following Baseline in the Barnes Akathisia Scale (BARS) Total Score	-0.3 Units on a scale Standard Deviation 1.05	-0.1 Units on a scale Standard Deviation 0.53	-0.1 Units on a scale Standard Deviation 0.53	-0.1 Units on a scale Standard Deviation 1.07

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=15 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=14 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in the Barnes Akathisia Scale (BARS) Total Score	-0.4 Units on a scale Standard Deviation 1.12	-0.2 Units on a scale Standard Deviation 0.55	0.0 Units on a scale Standard Deviation 0.85	0.1 Units on a scale Standard Deviation 0.66

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Barnes Akathisia Scale (BARS) Total Score	0.2 Units on a scale Standard Deviation 0.83	0.1 Units on a scale Standard Deviation 1.08	-0.3 Units on a scale Standard Deviation 0.62	0.4 Units on a scale Standard Deviation 1.71

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The BARS is a 4-item clinician-rated scale to measure the presence and severity of drug-induced akathisia. Items related to the assessment of objective akathisia, subjective awareness of restlessness, and distress related to restlessness are rated using various 4-point (0 - 3) scales. A global assessment of akathisia is rated using a 6-point (0=Absent, 1=Questionable akathisia, 2=Mild akathisia, 3=Moderate akathisia, 4=Marked akathisia, 5=Severe akathisia) scale. The total score range is from 0 to 14 with a higher score indicating more severe akathisia.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Barnes Akathisia Scale (BARS) Total Score	-0.1 Units on a scale Standard Error 0.29	-0.2 Units on a scale Standard Error 0.58	-0.2 Units on a scale Standard Error 0.58	-0.1 Units on a scale Standard Error 1.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.

The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 or the last observation following baseline in the total score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=15 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=14 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score	0.2 Units on a scale Standard Deviation 2.14	-0.4 Units on a scale Standard Deviation 1.83	0.3 Units on a scale Standard Deviation 2.19	0.1 Units on a scale Standard Deviation 1.29

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 2 in the total score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score	0.7 Units on a scale Standard Deviation 2.75	-1.1 Units on a scale Standard Deviation 1.93	-0.8 Units on a scale Standard Deviation 1.19	0.4 Units on a scale Standard Deviation 1.26

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

The CDSS is a clinician-rated scale that assesses the level of depression in patients with schizophrenia. Each of the 9 items is scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score range is 0 - 27. The data presented here represents the change from Baseline to Week 4 in the total score.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 on the Calgary Depression Scale for Schizophrenia (CDSS) Total Score	0.0 Units on a scale Standard Deviation 2.26	-0.6 Units on a scale Standard Deviation 1.93	0.3 Units on a scale Standard Deviation 2.19	0.2 Units on a scale Standard Deviation 1.34

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks (or last observation after Baseline)

Population: Safety Analysis Set defined as subjects who had at least one dose of study medication and an observation at baseline and at least one observation after baseline.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Endpoint.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=15 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=14 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=14 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score	-0.7 Units on a scale Standard Deviation 2.05	0.1 Units on a scale Standard Deviation 3.34	-0.4 Units on a scale Standard Deviation 2.69	-0.9 Units on a scale Standard Deviation 1.21

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 1 week following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 1. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 1.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=15 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=14 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score	0.3 Units on a scale Standard Deviation 1.71	-0.1 Units on a scale Standard Deviation 1.71	0.3 Units on a scale Standard Deviation 2.50	-0.6 Units on a scale Standard Deviation 1.50

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 2 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 2. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 2.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=13 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score	-0.3 Units on a scale Standard Deviation 1.65	-1.1 Units on a scale Standard Deviation 1.88	0.4 Units on a scale Standard Deviation 2.19	-0.9 Units on a scale Standard Deviation 1.04

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks following the start of study drug administration

Population: Full analysis set defined as subjects who received one or more doses of the study drug and whose clinician completed an efficacy assessment at week 4. Summary statistics are provided for the observed data only, missing data was not estimated.

PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The Positive Scale score ranges from 7 to 49. The data here represents the change in Positive Rating Scale from Baseline to Week 4.

Outcome measures

Outcome measures
Measure	Armodafinil 50 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=12 Participants Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=13 Participants Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Positive Scale Score	-0.7 Units on a scale Standard Deviation 2.02	-0.8 Units on a scale Standard Deviation 2.41	-0.6 Units on a scale Standard Deviation 2.71	-1.0 Units on a scale Standard Deviation 1.22

Adverse Events

Armodafinil 50 mg/Day

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Armodafinil 100 mg/Day

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Armodafinil 200 mg/Day

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Armodafinil 50 mg/Day n=15 participants at risk Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 100 mg/Day n=15 participants at risk Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.	Armodafinil 200 mg/Day n=15 participants at risk Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.	Placebo n=14 participants at risk Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
Psychiatric disorders Psychotic disorder	0.00% 0/15 • Adverse events were collected over a six weeks beginning with the Screening period (1 week), 4 weeks double-blind treatment and 1 week follow up. For subjects who discontinued early the follow up period was defined as 7 days after the final study visit.	0.00% 0/15 • Adverse events were collected over a six weeks beginning with the Screening period (1 week), 4 weeks double-blind treatment and 1 week follow up. For subjects who discontinued early the follow up period was defined as 7 days after the final study visit.	0.00% 0/15 • Adverse events were collected over a six weeks beginning with the Screening period (1 week), 4 weeks double-blind treatment and 1 week follow up. For subjects who discontinued early the follow up period was defined as 7 days after the final study visit.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a six weeks beginning with the Screening period (1 week), 4 weeks double-blind treatment and 1 week follow up. For subjects who discontinued early the follow up period was defined as 7 days after the final study visit.

Other adverse events

Additional Information

Medical Monitor

Cephalon, Inc.

Phone: 1-800-896-5855

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60