Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia

This is a multicenter, randomized, double-blind, placebo- and active-controlled trial to
evaluate the safety and efficacy of brexpiprazole monotherapy compared to placebo in
adolescent subjects (ages 13-17) with a DSM-5 diagnosis of schizophrenia.

Inclusion Criteria:

- Male & female subjects aged 13-17 years, inclusive at time of consent and at baseline
visit, with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and
confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to
screening.

- PANSS score >= 80, inclusive, at screening and baseline

Exclusion Criteria:

- Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary
focus of treatment within 3 months of screening.

- Subjects with a clinical presentation or history that is consistent with delirium,
dementia, amnesia or other cognitive disorders

- Subjects who have been hospitalized > 21 days for a current exacerbation of
schizophrenia at the time of baseline.

- Any neurological disorder other than Tourette's Syndrome

- Subjects at significant risk of committing violent acts, serious self-harm or suicide
based on history

- Subjects with epilepsy, a history of seizures, severe head trauma or stroke

- Subjects who test positive for drugs of abuse at screening