A multicenter, active-controlled, double-blind, parallel group-comparison trial to investigate the efficacy and safety of aripiprazole IM depot (OPC-14597IMD) compared with aripiprazole tablets in patients with schizophrenia

INTERVENTION: Intervention name : Aripiprazole Dosage And administration of the intervention : IM depot will be administered into the gluteal muscle once every 4 weeks, over a period of 52 weeks Control intervention name : Aripiprazole Dosage And administration of the control intervention : tablets will be orally administered once daily over a period of 52 weeks at the dose administered at the end of Phase 2 CONDITION: Schizophrenia PRIMARY OUTCOME: Non‐exacerbation of psychotic symptoms/non‐relapse rate in Phase 3 SECONDARY OUTCOME: PANSS scale total score INCLUSION CRITERIA: 1) Subjects with a current diagnosis of schizophrenia as defined by DSM‐IV‐TR criteria 2) Subjects who provide written consent personally 3) Male and female subjects aged 18 years or older at time of informed consent