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

A Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 Years Old) With Schizophrenia

To determine the 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