Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia

Schizophrenia is a severely delibitating mental illness that affects approximately 1% of the
world population. The onset of schizophrenia symptoms typically peaks in late adolescence
and early adulthood. In a minority of cases, the initial episode may occur during childhood
or early adolescence. Patients who experience this "early-onset schizophrenia" exhibit
symptoms that are more severe and follow a more chronic course; adolescents with
schizophrenia may never achieve full remission of the initial episode. The prognosis for
early-onset schizophrenia tends to be poor, and cognitive impairment is greater compared
with individuals whose onset of schizophrenia occurs later in life. Several antipsychotics
have been investigated for the treatment of adolescent schizophrenia, however, there is a
particular challenge because developing bodies are more sensitive to side effects of
antipsychotics, particularly with respect to weight gain. In order to enroll a population
that includes the younger ages, adolescents with other related psychiatric disorders are
also included in this study.

Inclusion Criteria:

- Male and female subjects 13 to 17 years of age, inclusive, at the time of informed
consent.

- Subjects with a current diagnosis of primary schizophrenia spectrum or bipolar
spectrum disorder, as defined by DSM-IV-TR criteria, and confirmed by K-SADS-PL.

- No psychiatric hospitalizations within the past 12 weeks.

- Subjects require treatment with antipsychotic medications.

- Subjects who have received previous outpatient antipsychotic treatment at an adequate
dose for an adequate duration (at least 6 weeks) and who showed a previous good
response to such antipsychotic treatment (other than clozapine) in the last 12
months.

- Subjects with a body weight at Screening greater than or equal to 30 kg.

Exclusion Criteria:

- Sexually active females of childbearing potential and male subjects who are not
practicing two different methods of birth control with their partner (or abstinence)
during the trial and for 30 days after the last dose of trial medication

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

- Subjects who have received continuous medication therapy to treat schizophrenia and
schizophrenia spectrum diagnosis for less than six months prior to first dose of
study medication AND subjects who have received continuous medication therapy to
treat bipolar and bipolar spectrum disorder for less than two months in the past
three years; or subjects who require more than one antipsychotic..

- Subjects with a current DSM-IV-TR diagnosis other than schizophrenia spectrum ,
bipolar spectrum, including any Axis I or Axis II (DSM-IV-TR) disorder.

- Subjects with a clinical presentation and/or history of any neurodevelopmental
disorder

- Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the
past 180 days.

- Subjects who currently have clinically significant neurological, hepatic, renal,
metabolic, hematological, immunological, cardiovascular, pulmonary, or
gastrointestinal disorders such as any history of myocardial infarction, congestive
heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic
hepatitis B or C.

- Subjects with IDDM (ie, any subjects using insulin) are excluded. Subjects with
non-IDDM may be eligible for the trial if their condition is stable.

- Subjects with epilepsy or a history of seizures.

- Any major surgery or blood transfusion within 30 days prior to first dose of trial
medication.

- Subjects with a positive drug screen for cocaine or other illicit drugs, or alcohol
are excluded and may not be retested or re-screened.

- Prohibited concomitant medications used within the exclusionary period prior to Day 1
of the Dose Escalation Phase or anticipated need for such medications during the
trial.

- Subjects who participated in a clinical trial and were exposed to IMP within the last
30 days or who participated in more than two interventional clinical trials within
the past year.

- Subjects with a history of true allergic response (ie, not intolerance) to more than
one class of medications.

- Inability to tolerate oral medication or swallow tablets.