Trial Outcomes & Findings for Modafinil Effects on Cognition in Schizophrenia Patients (NCT NCT00711464)

NCT ID: NCT00711464

Last Updated: 2017-09-29

Results Overview

Percent Accuracy on high-control (i.e. difficult) condition on test of cognitive control

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 29 participants
• Primary outcome timeframe: 3-5 hours
• Results posted on: 2017-09-29

Participant Flow

Participant milestones

Measure	All Participants modafinil 100 milligrams oral dose, 200 milligrams oral dose, 400 milligrams oral dose, and placebo, in randomly sequenced dosing periods.
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modafinil Effects on Cognition in Schizophrenia Patients

Baseline characteristics by cohort

Measure	All Participants n=29 Participants modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose, and placebo, in random sequence.
Age, Continuous	31 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 3-5 hours

Percent Accuracy on high-control (i.e. difficult) condition on test of cognitive control

Outcome measures

Measure	100 mg n=29 Participants modafinil 100 milligrams oral dose modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose	200 mg n=29 Participants modafinil 200 mg oral dose modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose	400 mg n=29 Participants modafinil 400 mg oral dose modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose	Placebo n=29 Participants Single oral placebo capsule modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose
Cognitive Performance	76.7 percentage correct of all trials Standard Deviation 22.8	75.5 percentage correct of all trials Standard Deviation 26.8	67.2 percentage correct of all trials Standard Deviation 33.2	77.1 percentage correct of all trials Standard Deviation 26.3

SECONDARY outcome

Timeframe: 3-5 hours

systolic blood pressure in mm Hg

Outcome measures

Measure	100 mg n=29 Participants modafinil 100 milligrams oral dose modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose	200 mg n=29 Participants modafinil 200 mg oral dose modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose	400 mg n=29 Participants modafinil 400 mg oral dose modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose	Placebo n=29 Participants Single oral placebo capsule modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose
Systolic Blood Pressure	109 mm Hg Standard Deviation 16	112 mm Hg Standard Deviation 14	116 mm Hg Standard Deviation 16	111 mm Hg Standard Deviation 10

SECONDARY outcome

Timeframe: 3-5 hours

beats per minute

Outcome measures

Measure	100 mg n=29 Participants modafinil 100 milligrams oral dose modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose	200 mg n=29 Participants modafinil 200 mg oral dose modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose	400 mg n=29 Participants modafinil 400 mg oral dose modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose	Placebo n=29 Participants Single oral placebo capsule modafinil (M1, M2, M4): modafinil 100, 200, and 400 mg oral dose
Heart Rate	74 beats per minute Standard Deviation 10	81 beats per minute Standard Deviation 12	86 beats per minute Standard Deviation 16	76 beats per minute Standard Deviation 12

Adverse Events

100 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

200 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

400 mg

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, MD

University of California, Los Angeles

Phone: (310) 825-7642

Email: MMinzenberg@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place