Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia

Inclusion Criteria: Have 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 both the Mini International Neuropsychiatric Interview (M.I.N.I.) for
Schizophrenia and Psychotic Disorders Studies and an adequate clinical psychiatric
evaluation.

- Had the start of their first schizophrenia episode ≤ 5 years before the time of
consent.

- Are 18 to 35 years old at the time of consent (inclusive, and outpatients only).

- Have a Positive and Negative Syndrome Scale (PANSS) Total Score of ≤ 80 at screening
and baseline.

- Exhibit schizophrenia symptoms with a score ≥ 4 on the PANSS for ≥1 items related to
active social avoidance, emotional withdrawal, passive/apathetic social withdrawal,
and difficulty in abstract thinking.

- Have a diagnosis of schizophrenia made at least 6 months prior to screening as
confirmed by subject, caregiver, or documented history.

Exclusion Criteria: Subjects presenting with a first episode of schizophrenia based on the
clinical judgment of the investigator.

- Subjects who have been hospitalized for psychotic symptoms within the last 6 months.

- Subjects with schizophrenia who are considered resistant/refractory to antipsychotic
treatment by history or who have a history of failure to respond to clozapine or
response to clozapine treatment only.

- Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia,
including, but not limited to, schizoaffective disorder, MDD, bipolar disorder,
post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or
other cognitive disorders. Also, subjects with borderline, paranoid, histrionic,
schizotypal, schizoid, or antisocial personality disorders.

- Subjects experiencing acute depressive symptoms within the past 30 days, according to
the investigator's opinion, that require treatment with an antidepressant.

- Subjects with clinically significant tardive dyskinesia at enrollment, as determined
by a score of>= 3 on Item 8 of the AIMS at screening or baseline.

- Subjects with a score of 5 (severe akathisia) on the BARS global clinical assessment
of akathisia at screening or baseline.

- Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the
past 180 days; including alcohol and benzodiazepines, but excluding nicotine.