Conditions: Schizophrenia
Keywords: Schizophrenia Relapsed
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 459
Healthy volunteers: no

Brief summary:
This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay sensitivity of the study. A total of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.

Detailed description:

Arms:
arm 1: OPC-34712 0.25 mg arm arm 2: OPC-34712 low-dose arm arm 3: OPC-34712 mid-dose arm arm 4: OPC-34712 high-dose arm arm 5: None arm 6: Aripiprazole arm

Interventions: intervention 1: OPC-34712 intervention 2: Placebo intervention 3: Aripiprazole
Intervention descriptions: intervention 1: oral, once daily intervention 2: Placebo intervention 3: oral, once daily

Protocol document: