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

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the safety & efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: H. Lundbeck A/S
• Treatments: Aripiprazole; Brexpiprazole

Criteria

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