A Phase 2, 6-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 Once Daily and Aripiprazole Once Daily for Treatment of Hospitalized Adult Patients With Acute Schizophrenia
A Phase 2, 6-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 Once Daily and Aripiprazole Once Daily for Treatment of Hospitalized Adult Patients With Acute Schizophrenia
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.
Inclusion Criteria:
Exclusion Criteria:
Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
Subjects with a current DSM-IV-TR Axis I diagnosis of:
Subjects presenting with a first episode of schizophrenia
Other protocol specific inclusion/exclusion criteria may apply
Vijaywada, Andh Prad 520002, India
Moscow Region, 141371, Russia
Hualien Town, 970, Taiwan
Vinnitsia, 21018, Ukraine