Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia

Protocol 331-13-008: An Exploratory, Multicenter, Open-label, Flexible-dose Brexpiprazole (OPC-34712) Trial in Adults With Acute Schizophrenia

The purpose of this study is to explore changes in efficacy, cognitive functioning, and safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia

Inclusion Criteria:

• 18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies
• Would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry
• Are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by all of the following:
• Positive and Negative Syndrome Scale (PANSS) Total Score of ≥ 80
• Score of ≥ 4 on two or more of the following PANSS items at screening: hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness
• Clinical Global Impression - Severity of Illness Scale (CGI-S) score ≥ 4 (moderately ill)

Exclusion Criteria:

• Are presenting with a first episode of schizophrenia based on the clinical judgment of the investigator
• Have been hospitalized > 21 days for the current acute episode at the time of the baseline visit
• Have a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders; also borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders or mental retardation.
• Improvement of ≥ 20% in total PANSS score between the screening and baseline assessments.