Conditions: Schizophrenia
Keywords: Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 340
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to evaluate the overall efficacy of aripiprazole intramuscular (IM) depot as acute treatment in subjects with schizophrenia.

The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.

Detailed description:

Arms:
arm 1: Aripiprazole IM Depot 400 mg, with allowed decrease to 300 mg for safety and return to 400 mg for efficacy if needed, every four weeks for 12 weeks arm 2: Matching placebo

Interventions: intervention 1: Aripiprazole IM Depot intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Matching Placebo

Protocol document: