Trial Outcomes & Findings for The Effects of Aripiprazole on the Processing of Rewards in Schizophrenia (NCT NCT00209027)

NCT ID: NCT00209027

Last Updated: 2013-12-06

Results Overview

fMRI BOLD activation during a reward task will be compared between schizophrenia subjects and controls at Baseline. Schizophrenia subjects will switch their baseline medication to aripiprazole and their BOLD activation during the reward task at Baseline will be compared to the endpoint scan.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2013-12-06

Participant Flow

Participant milestones

Measure	Schizophrenia Subjects Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.	Controls Baseline fMRI scan
Overall Study STARTED	10	10
Overall Study COMPLETED	0	10
Overall Study NOT COMPLETED	10	0

Reasons for withdrawal

Measure	Schizophrenia Subjects Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.	Controls Baseline fMRI scan
Overall Study study terminated	10	0

Baseline Characteristics

The Effects of Aripiprazole on the Processing of Rewards in Schizophrenia

Baseline characteristics by cohort

Measure	Schizophrenia Subjects n=10 Participants Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.	Controls n=10 Participants Baseline fMRI scan	Total n=20 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	10 Participants n=5 Participants	10 Participants n=7 Participants	20 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	42.5 years STANDARD_DEVIATION 10.9 • n=5 Participants	38.6 years STANDARD_DEVIATION 7.2 • n=7 Participants	40.6 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Prespecified data not collected because the study was terminated before subjects received aripiprazole.

fMRI BOLD activation during a reward task will be compared between schizophrenia subjects and controls at Baseline. Schizophrenia subjects will switch their baseline medication to aripiprazole and their BOLD activation during the reward task at Baseline will be compared to the endpoint scan.

Outcome measures

Outcome data not reported

Adverse Events

Schizophrenia Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

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

Erica Duncan

Emory University

Phone: 404-321-6111

Email: erica.duncan@va.gov

Results disclosure agreements

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

Restriction type: LTE60