Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia

• Status: Recruiting
• Trial end date: 2026-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia

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

Details

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

Criteria

Inclusion Criteria:

• Male & female subjects 13-17 years of age, inclusive.

• Subjects who turn 18 during trial 331-10-234 are permitted in this trial.

• Subjects with a current primary diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by the K-SADS-PL completed at time of entry into Trial 331-10-234. For de novo subjects who did not participate in Trial 331-10-234, the initial diagnosis of schizophrenia must be made and documented, and the diagnosis confirmed by the K-SADS-PL at screening.

• Subjects who, in the investigator's judgment, require treatment with antipsychotic medication(s).

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 with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (e.g., medication, illicit drug use).

• History of failure of clozapine treatment or response to clozapine treatment only.

• History of neuroleptic malignant syndrome