Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder (NCT NCT01305408)
NCT ID: NCT01305408
Last Updated: 2016-05-26
Results Overview
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
COMPLETED
PHASE3
399 participants
Day 0 (baseline), Week 8
2016-05-26
Participant Flow
Region 1: USA and Canada Region 2: Eastern European countries, Kyrgyzstan, Mongolia, Uzbekistan, Cyprus, Greece, and Turkey Region 3: Central and Northern European countries, Andorra, Australia, Iceland, Monaco, San Marino, and Vatican City Region 4: Rest of World
Participants were randomized (1:1) to receive150 mg/day armodafinil or matching placebo. Randomization was stratified on the basis of the mood-stabilizing medication and region of the world.
Participant milestones
| Measure |
Placebo
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
200
|
|
Overall Study
Safety Population
|
198
|
200
|
|
Overall Study
Full Analysis Population
|
196
|
197
|
|
Overall Study
COMPLETED
|
167
|
169
|
|
Overall Study
NOT COMPLETED
|
32
|
31
|
Reasons for withdrawal
| Measure |
Placebo
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
7
|
|
Overall Study
Lack of Efficacy
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
9
|
9
|
|
Overall Study
Protocol Violation
|
4
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Noncompliance with study medication
|
0
|
1
|
|
Overall Study
Noncompliance with study procedures
|
0
|
1
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=199 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 11.26 • n=7 Participants
|
44.5 years
STANDARD_DEVIATION 11.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
183 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
359 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
176 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
358 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Weight
|
81.2 kg
STANDARD_DEVIATION 17.46 • n=5 Participants
|
80.7 kg
STANDARD_DEVIATION 17.54 • n=7 Participants
|
80.9 kg
STANDARD_DEVIATION 17.48 • n=5 Participants
|
|
Height
|
168.4 cm
STANDARD_DEVIATION 9.32 • n=5 Participants
|
168.9 cm
STANDARD_DEVIATION 9.23 • n=7 Participants
|
168.6 cm
STANDARD_DEVIATION 9.27 • n=5 Participants
|
|
Body Mass Index
|
28.7 kg/m^2
STANDARD_DEVIATION 5.95 • n=5 Participants
|
28.2 kg/m^2
STANDARD_DEVIATION 5.52 • n=7 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 5.73 • n=5 Participants
|
|
Time Since Start of Current Depressive Episode
|
12.1 weeks
STANDARD_DEVIATION 9.10 • n=5 Participants
|
12.3 weeks
STANDARD_DEVIATION 9.89 • n=7 Participants
|
12.2 weeks
STANDARD_DEVIATION 9.49 • n=5 Participants
|
|
Time Since First Diagnosis for Bipolar
|
9.9 years
STANDARD_DEVIATION 8.72 • n=5 Participants
|
10.7 years
STANDARD_DEVIATION 8.55 • n=7 Participants
|
10.3 years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (baseline), Week 8Population: Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Outcome measures
| Measure |
Placebo
n=196 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=197 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
|
-19.4 units on a scale
Standard Error 0.99
|
-20.8 units on a scale
Standard Error 0.99
|
SECONDARY outcome
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.
A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.
Outcome measures
| Measure |
Placebo
n=196 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=197 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Week 1 (196, 195)
|
2 percentage of participants
|
3 percentage of participants
|
|
Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Week 2 (187, 189)
|
13 percentage of participants
|
9 percentage of participants
|
|
Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Week 4 (181, 183)
|
21 percentage of participants
|
27 percentage of participants
|
|
Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Week 6 (172, 172)
|
29 percentage of participants
|
41 percentage of participants
|
|
Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Week 7 (167, 170)
|
39 percentage of participants
|
51 percentage of participants
|
|
Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Week 8 (167, 169)
|
46 percentage of participants
|
56 percentage of participants
|
|
Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Endpoint (196, 197)
|
41 percentage of participants
|
49 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.
A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.
Outcome measures
| Measure |
Placebo
n=196 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=197 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Week 1 (196, 195)
|
.5 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Week 2 (187, 189)
|
2 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Week 4 (181, 183)
|
5 percentage of participants
|
7 percentage of participants
|
|
Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Week 6 (172, 172)
|
9 percentage of participants
|
12 percentage of participants
|
|
Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Week 7 (167, 170)
|
14 percentage of participants
|
19 percentage of participants
|
|
Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Week 8 (167, 169)
|
15 percentage of participants
|
26 percentage of participants
|
|
Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Endpoint (196, 197)
|
13 percentage of participants
|
22 percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Outcome measures
| Measure |
Placebo
n=196 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=197 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Week 4 (181, 183)
|
-13.4 units on a scale
Standard Deviation 9.87
|
-13.5 units on a scale
Standard Deviation 10.54
|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Week 1 (196, 195)
|
-6.0 units on a scale
Standard Deviation 6.61
|
-5.3 units on a scale
Standard Deviation 7.12
|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Week 2 (187, 189)
|
-10.0 units on a scale
Standard Deviation 8.71
|
-8.9 units on a scale
Standard Deviation 8.56
|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Week 6 (172, 172)
|
-15.8 units on a scale
Standard Deviation 10.42
|
-17.6 units on a scale
Standard Deviation 11.09
|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Week 7 (167, 170)
|
-18.0 units on a scale
Standard Deviation 11.42
|
-20.2 units on a scale
Standard Deviation 10.88
|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Week 8 (167, 169)
|
-19.7 units on a scale
Standard Deviation 11.30
|
-21.6 units on a scale
Standard Deviation 11.75
|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Endpoint (196, 197)
|
-18.3 units on a scale
Standard Deviation 11.62
|
-19.5 units on a scale
Standard Deviation 12.66
|
SECONDARY outcome
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit are those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.
The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Outcome measures
| Measure |
Placebo
n=196 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=197 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
Week 1 (196, 195)
|
-2.4 units on a scale
Standard Deviation 2.92
|
-2.1 units on a scale
Standard Deviation 3.07
|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
Week 2 (187, 189)
|
-4.2 units on a scale
Standard Deviation 3.83
|
-3.4 units on a scale
Standard Deviation 3.63
|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
Week 4 (181, 183)
|
-5.3 units on a scale
Standard Deviation 4.05
|
-5.3 units on a scale
Standard Deviation 4.15
|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
Week 6 (172, 172)
|
-6.3 units on a scale
Standard Deviation 4.16
|
-6.7 units on a scale
Standard Deviation 4.38
|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
Week 7 (167, 170)
|
-7.2 units on a scale
Standard Deviation 4.49
|
-7.8 units on a scale
Standard Deviation 4.35
|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
Week 8 (167, 169)
|
-8.0 units on a scale
Standard Deviation 4.53
|
-8.3 units on a scale
Standard Deviation 4.62
|
|
Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
Endpoint (196, 197)
|
-7.3 units on a scale
Standard Deviation 4.73
|
-7.5 units on a scale
Standard Deviation 4.91
|
SECONDARY outcome
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.
The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.
Outcome measures
| Measure |
Placebo
n=196 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=197 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
Endpoint (196, 197)
|
-1.2 units on a scale
Standard Deviation 1.14
|
-1.4 units on a scale
Standard Deviation 1.25
|
|
Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
Week 1 (196, 195)
|
-0.2 units on a scale
Standard Deviation 0.49
|
-0.2 units on a scale
Standard Deviation 0.46
|
|
Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
Week 2 (187, 189)
|
-0.5 units on a scale
Standard Deviation 0.65
|
-0.5 units on a scale
Standard Deviation 0.77
|
|
Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
Week 4 (181, 183)
|
-0.7 units on a scale
Standard Deviation 0.76
|
-0.9 units on a scale
Standard Deviation 0.97
|
|
Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
Week 6 (172, 172)
|
-1.0 units on a scale
Standard Deviation 0.91
|
-1.2 units on a scale
Standard Deviation 1.03
|
|
Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
Week 7 (167, 170)
|
-1.2 units on a scale
Standard Deviation 1.08
|
-1.4 units on a scale
Standard Deviation 1.10
|
|
Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
Week 8 (167, 169)
|
-1.3 units on a scale
Standard Deviation 1.11
|
-1.6 units on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)Population: Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.
The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.
Outcome measures
| Measure |
Placebo
n=196 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=197 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale
Week 4 (181, 183)
|
5.8 units on a scale
Standard Deviation 7.39
|
8.2 units on a scale
Standard Deviation 10.39
|
|
Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale
Week 8 (167, 169)
|
11.5 units on a scale
Standard Deviation 10.42
|
15.3 units on a scale
Standard Deviation 11.72
|
|
Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale
Endpoint (189, 192)
|
10.6 units on a scale
Standard Deviation 10.42
|
13.6 units on a scale
Standard Deviation 12.38
|
SECONDARY outcome
Timeframe: Day 1 to Week 9Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug.
AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results. Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
>=1 adverse event
|
71 participants
|
89 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
Severe adverse event
|
4 participants
|
4 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
Treatment-related adverse event
|
32 participants
|
53 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
Deaths
|
0 participants
|
0 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
Other serious adverse events
|
6 participants
|
5 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
Withdrawn from study due to adverse events
|
10 participants
|
7 participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAE)
Protocol-defined adverse events
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Day 0 (baseline), last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.
The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.
Outcome measures
| Measure |
Placebo
n=196 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=198 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score
|
-1.0 units on a scale
Standard Deviation 2.45
|
-0.9 units on a scale
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: Day 0 (baseline), last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.
HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.
Outcome measures
| Measure |
Placebo
n=190 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=194 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
|
-4.2 units on a scale
Standard Deviation 4.53
|
-4.3 units on a scale
Standard Deviation 5.37
|
SECONDARY outcome
Timeframe: Day 0 (baseline), last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.
The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.
Outcome measures
| Measure |
Placebo
n=190 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=192 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
|
-7.0 units on a scale
Standard Deviation 6.62
|
-7.1 units on a scale
Standard Deviation 6.91
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
Week 1 (196, 195)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
Week 2 (187, 189)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
Week 4 (181, 183)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
Week 6 (172, 172)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
Week 7 (167, 170)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
Week 8 (167, 169)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
Endpoint (196, 198)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
Week 1 (196, 195)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
Week 2 (187, 189)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
Week 4 (181, 183)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
Week 6 (172, 172)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
Week 7 (167, 170)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
Week 8 (167, 169)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
Endpoint (196, 198)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
Week 1 (196, 195)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
Week 2 (187, 189)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
Week 4 (181, 183)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
Week 6 (172, 172)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
Week 7 (167, 170)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
Week 8 (167, 169)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
Endpoint (196, 198)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
Week 2 (187, 189)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
Week 1 (196, 195)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
Week 4 (181, 183)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
Week 6 (172, 172)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
Week 7 (167, 170)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
Week 8 (167, 169)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
Endpoint (196, 198)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
Week 1 (196, 195)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
Week 2 (187, 189)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
Week 4 (181, 183)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
Week 6 (172, 172)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
Week 7 (167, 170)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
Week 8 (167, 169)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
Endpoint (196, 198)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
Week 1 (196, 195)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
Week 2 (187, 189)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
Week 4 (181, 183)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
Week 6 (172, 172)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
Week 7 (167, 170)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
Week 8 (167, 169)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
Endpoint (196, 198)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
Week 4 (181, 183)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
Week 7 (167, 170)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
Week 1 (196, 195)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
Week 2 (187, 189)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
Week 6 (172, 172)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
Week 8 (167, 169)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
Endpoint (196, 198)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
Week 6 (172, 172)
|
2 participants
|
3 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
Week 1 (196, 195)
|
6 participants
|
5 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
Week 2 (187, 189)
|
2 participants
|
6 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
Week 4 (181, 183)
|
1 participants
|
7 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
Week 7 (167, 170)
|
2 participants
|
2 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
Week 8 (167, 169)
|
1 participants
|
3 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
Endpoint (196, 198)
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
Week 1 (196, 195)
|
2 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
Week 2 (187, 189)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
Week 4 (181, 183)
|
0 participants
|
1 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
Week 6 (172, 172)
|
0 participants
|
1 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
Week 7 (167, 170)
|
0 participants
|
1 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
Week 8 (167, 169)
|
0 participants
|
1 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
Endpoint (196, 198)
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
Week 1 (6, 5)
|
1 participants
|
1 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
Week 2 (2, 6)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
Week 4 (1, 7)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
Week 6 (1, 3)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
Week 7 (2, 2)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
Week 8 (1, 3)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
Endpoint (8, 12)
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
Week 1 (6, 5)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
Week 2 (2, 6)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
Week 4 (1, 7)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
Week 6 (1, 3)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
Week 7 (2, 2)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
Week 8 (1, 3)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
Endpoint (8, 12)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)Population: The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.
The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit.
Outcome measures
| Measure |
Placebo
n=198 Participants
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
Armodafinil 150 mg/Day
n=200 Participants
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
Week 1 (6, 5)
|
1 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
Week 2 (2, 6)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
Week 4 (1, 7)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
Week 6 (1, 3)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
Week 7 (2, 2)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
Week 8 (1, 3)
|
0 participants
|
0 participants
|
|
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
Endpoint (8, 12)
|
1 participants
|
0 participants
|
Adverse Events
Armodafinil 150 mg/Day
Placebo
Serious adverse events
| Measure |
Armodafinil 150 mg/Day
n=200 participants at risk
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
Placebo
n=198 participants at risk
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.50%
1/200 • Number of events 1 • Day 1 to Week 9
|
0.00%
0/198 • Day 1 to Week 9
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/200 • Day 1 to Week 9
|
0.51%
1/198 • Number of events 1 • Day 1 to Week 9
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.00%
0/200 • Day 1 to Week 9
|
0.51%
1/198 • Number of events 1 • Day 1 to Week 9
|
|
Psychiatric disorders
Anxiety
|
0.50%
1/200 • Number of events 1 • Day 1 to Week 9
|
0.00%
0/198 • Day 1 to Week 9
|
|
Psychiatric disorders
Bipolar I disorder
|
0.50%
1/200 • Number of events 1 • Day 1 to Week 9
|
0.00%
0/198 • Day 1 to Week 9
|
|
Psychiatric disorders
Depression
|
0.50%
1/200 • Number of events 1 • Day 1 to Week 9
|
0.00%
0/198 • Day 1 to Week 9
|
|
Psychiatric disorders
Hypomania
|
0.00%
0/200 • Day 1 to Week 9
|
0.51%
1/198 • Number of events 1 • Day 1 to Week 9
|
|
Psychiatric disorders
Insomnia
|
0.50%
1/200 • Number of events 1 • Day 1 to Week 9
|
0.00%
0/198 • Day 1 to Week 9
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/200 • Day 1 to Week 9
|
0.51%
1/198 • Number of events 1 • Day 1 to Week 9
|
|
Psychiatric disorders
Suicide attempt
|
0.50%
1/200 • Number of events 1 • Day 1 to Week 9
|
0.00%
0/198 • Day 1 to Week 9
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/200 • Day 1 to Week 9
|
0.51%
1/198 • Number of events 1 • Day 1 to Week 9
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/200 • Day 1 to Week 9
|
0.51%
1/198 • Number of events 1 • Day 1 to Week 9
|
|
Social circumstances
Social stay hospitalisation
|
0.50%
1/200 • Number of events 1 • Day 1 to Week 9
|
0.00%
0/198 • Day 1 to Week 9
|
Other adverse events
| Measure |
Armodafinil 150 mg/Day
n=200 participants at risk
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
|
Placebo
n=198 participants at risk
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.0%
12/200 • Number of events 13 • Day 1 to Week 9
|
3.5%
7/198 • Number of events 7 • Day 1 to Week 9
|
|
Nervous system disorders
Headache
|
14.5%
29/200 • Number of events 35 • Day 1 to Week 9
|
7.6%
15/198 • Number of events 17 • Day 1 to Week 9
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER