Trial Outcomes & Findings for Modafinil for Treatment of Cognitive Dysfunction in Schizophrenia (NCT NCT00423943)

Last Updated: 2017-09-29

Results Overview

Accuracy change on high-control (i.e., difficult) condition of Preparing to Overcome Prepotency (POP) Task. For high-control condition (red-cue), subjects responded in the incongruent direction (eg, for a right-pointing arrow, press the left button, and vice versa). Increased values indicate improved performance.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

33 participants

Primary outcome timeframe

Baseline, 4 weeks

Results posted on

2017-09-29

Participant Flow

Participant milestones

Participant milestones
Measure	Drug modafinil modafinil: 200 milligrams daily dose	Placebo placebo modafinil: 200 milligrams daily dose
Overall Study STARTED	19	14
Overall Study COMPLETED	16	13
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Drug modafinil modafinil: 200 milligrams daily dose	Placebo placebo modafinil: 200 milligrams daily dose
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Modafinil for Treatment of Cognitive Dysfunction in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Drug n=19 Participants modafinil modafinil: 200 milligrams daily dose	Placebo n=14 Participants placebo modafinil: 200 milligrams daily dose	Total n=33 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
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.4 years STANDARD_DEVIATION 7.7 • n=5 Participants	25.8 years STANDARD_DEVIATION 8.9 • n=7 Participants	26.2 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	5 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	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	7 Participants n=7 Participants	24 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	14 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks

Outcome measures

Outcome measures
Measure	Drug n=19 Participants modafinil modafinil: 200 milligrams daily dose	Placebo n=14 Participants placebo modafinil: 200 milligrams daily dose
Percent Change in Accuracy on High-control (i.e., Difficult) Condition of Preparing to Overcome Prepotency Task	8.6 percent change in accuracy Standard Deviation 9.8	9.2 percent change in accuracy Standard Deviation 9.7

PRIMARY outcome

Timeframe: 4 weeks

BOLD signal change on high-control (i.e. difficult) condition versus low-control (i.e. easy) condition, on Preparing to Overcome Prepotency Task, measured by fMRI after 4-week treatment.

Outcome measures

Outcome measures
Measure	Drug n=19 Participants modafinil modafinil: 200 milligrams daily dose	Placebo n=14 Participants placebo modafinil: 200 milligrams daily dose
Control-related BOLD Signal Change in Locus Coeruleus	-0.05 beta coefficient of BOLD signal change Standard Deviation 0.63	-0.74 beta coefficient of BOLD signal change Standard Deviation 1.28

PRIMARY outcome

Timeframe: 4 weeks

Population: 2 subjects in the Drug arm refused to perform EEG.

Power in Gamma frequency range by scalp electrophysiology after single-dose and after 4-week treatment: Count of Clusters (defined as those with statistically-significant Task-Related Increase, i.e. relatively larger value of wavelet coefficient in wavelet analysis of signal) for high-control (i.e. difficult) condition versus Low-control (i.e. easy) condition, in Oscillatory Power in Time-Frequency Spectrogram. Increased values indicate improved function.

Outcome measures

Outcome measures
Measure	Drug n=14 Participants modafinil modafinil: 200 milligrams daily dose	Placebo n=13 Participants placebo modafinil: 200 milligrams daily dose
Gamma Power Change in Count of Clusters	44 Count of Positive Power Clusters Standard Deviation 12	17 Count of Positive Power Clusters Standard Deviation 5

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Change in Average score (range 0-5) on the Scale for Assessment of Positive Symptoms (SAPS) from baseline to 4 week time-point, ranging from 0 (absent) to 5 (severe). Decreased values indicate improved clinical status (lesser symptom severity).

Outcome measures

Outcome measures
Measure	Drug n=19 Participants modafinil modafinil: 200 milligrams daily dose	Placebo n=14 Participants placebo modafinil: 200 milligrams daily dose
Change in Positive Symptoms	0.80 units on a scale Standard Deviation 0.82	0.58 units on a scale Standard Deviation 0.56

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Change in average score, ranging from 0 (absent) to 5 (severe), on on Scale for the Assessment of Negative Symptoms (SANS) from baseline to 4-week time-point. Decreased values indicate improved clinical status (lesser symptom severity).

Outcome measures

Outcome measures
Measure	Drug n=19 Participants modafinil modafinil: 200 milligrams daily dose	Placebo n=14 Participants placebo modafinil: 200 milligrams daily dose
Change in Negative Symptoms	1.88 units on SANS scale Standard Deviation 1.04	2.12 units on SANS scale Standard Deviation 1.15

Adverse Events

Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Minzenberg

University of California, Los Angeles

Phone: 310-825-7642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place