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

Inclusion Criteria:

• 18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis ofschizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders,Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini InternationalNeuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies

• Would benefit from hospitalization or continued hospitalization for treatment of acurrent acute relapse of schizophrenia at trial entry

• Are experiencing an acute exacerbation of psychotic symptoms and marked deteriorationof 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: hallucinatorybehavior, unusual thought content, conceptual disorganization, or suspiciousness

• Clinical Global Impression - Severity of Illness Scale (CGI-S) score ≥ 4 (moderatelyill)

Exclusion Criteria:

• Are presenting with a first episode of schizophrenia based on the clinical judgment ofthe investigator

• Have been hospitalized > 21 days for the current acute episode at the time of thebaseline visit

• Have a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but notlimited to, schizoaffective disorder, major depressive disorder (MDD), bipolardisorder, 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 baselineassessments.