Trial Outcomes & Findings for Antipsychotic Effects on Brain Function in Schizophrenia (NCT NCT01913327)

Results Overview

The magnitude of BOLD signal change associated with cognitive task performance will be directly compared between the aripiprazole and risperidone-treated groups, as well as the degree of functional connectivity between the locus coeruleus and the prefrontal cortex, also during during cognitive task performance.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-04-20

Participant Flow

One subject was immediately lost to followup prior to treatment randomization; a second subject dropped out due to non-serious side effects commonly-associated with study drug Risperidone.

Participant milestones

Participant milestones
Measure	Aripiprazole aripiprazole with flexible, blind dosing between 7.5 mg and 30 mg, once daily. Aripiprazole Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication.	Risperidone risperidone with flexible, blind dosing between 1 mg and 8 mg, once daily. Risperidone: Week One, Risperidone 1 mg po qd; Week Two, 2 mg po qd; Week Three, 4 mg po qd; Week Four, 6 mg po qd; Week Five (and thereafter), 8 mg po qd. Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication.
Overall Study STARTED	1	2
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Aripiprazole aripiprazole with flexible, blind dosing between 7.5 mg and 30 mg, once daily. Aripiprazole Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication.	Risperidone risperidone with flexible, blind dosing between 1 mg and 8 mg, once daily. Risperidone: Week One, Risperidone 1 mg po qd; Week Two, 2 mg po qd; Week Three, 4 mg po qd; Week Four, 6 mg po qd; Week Five (and thereafter), 8 mg po qd. Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Antipsychotic Effects on Brain Function in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole n=1 Participants aripiprazole with flexible, blind dosing between 7.5 mg and 30 mg, once daily. Aripiprazole Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication.	Risperidone n=2 Participants risperidone with flexible, blind dosing between 1 mg and 8 mg, once daily. Risperidone: Week One, Risperidone 1 mg po qd; Week Two, 2 mg po qd; Week Three, 4 mg po qd; Week Four, 6 mg po qd; Week Five (and thereafter), 8 mg po qd. Modafinil: Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication.	Total n=3 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Trial was terminated early therefore no outcome data are available.

The magnitude of BOLD signal change associated with cognitive task performance will be directly compared between the aripiprazole and risperidone-treated groups, as well as the degree of functional connectivity between the locus coeruleus and the prefrontal cortex, also during during cognitive task performance.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: Trial was terminated early therefore no outcome data are available.

Performance on the cognitive task administered during fMRI will be directly compared between the two treatment groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one day

Population: Trial was terminated early therefore there are no outcome data.

Patterns of brain activation during cognitive task performance will be compared after modafinil versus after placebo, in the two antipsychotic-treated groups after 8 weeks of antipsychotic treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

Population: Trial was terminated early therefore no outcome data are available.

Common symptoms of schizophrenia (including psychotic symptoms, negative symptoms, depression symptoms) will be directly compared between the aripiprazole and risperidone-treated groups.

Outcome measures

Outcome data not reported

Adverse Events

Aripiprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Risperidone

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 San Francisco

Phone: 5104122199

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place