Conditions: Schizophrenia
Keywords: Schizophrenia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 74
Healthy volunteers: no

Brief summary:
The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297) will allow the subjects who complete Trial 291 to enter this open label trial at the investigator's discretion, where additional safety and tolerability data will be collected.

Detailed description:

Arms:
arm 1: Aripiprazole IM Depot 400 mg or 300 mg once monthly (every 28 days) for 24 weeks

Interventions: intervention 1: Aripiprazole IM Depot
Intervention descriptions: intervention 1: Aripiprazole IM Depot 400 mg or 300 mg

Protocol document: