Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Brexpiprazole

Criteria

Inclusion Criteria:

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria

2. Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia

3. Subjects experiencing an acute exacerbation of psychotic symptoms

4. Other protocol specific inclusion criteria may apply

Exclusion Criteria:

1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug

2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

• Schizoaffective disorder

• Major depressive disorder (MDD)

• Bipolar disorder

• Delirium, dementia, amnestic or other cognitive disorder

• Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder

3. Subjects presenting with a first episode of schizophrenia

4. Other protocol specific exclusion criteria may apply