Conditions: Schizophrenia
Keywords: Schizophrenia Aripiprazole
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 302
Healthy volunteers: no

Brief summary:
The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.

Detailed description:

Arms:
arm 1: Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25 arm 2: Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25 arm 3: Participants were given a single pill administered once daily

Interventions: intervention 1: Aripiprazole tablet, 10 mg intervention 2: Aripiprazole tablet, 30 mg intervention 3: Placebo tablet
Intervention descriptions: intervention 1: Aripiprazole tablet 10 mg po qd x 42 days intervention 2: Aripiprazole tablet 30 mg po qd x 42 days intervention 3: Placebo tablet po qd x 42 days

Protocol document: