NCT03238326

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

A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents (13-17 Years Old) With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 295 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a long-term, multicenter, open-label trial designed to examine the long-term safety and tolerability of brexpiprazole in adolescent participants (ages 13-17) with a DSM-5 diagnosis of schizophrenia.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Brexpiprazole	Once daily, oral tablets

Timeline

• Start date: 2017-08-23
• Primary completion: 2025-04-22
• Completion: 2025-04-22
• First posted: 2017-08-03
• Last updated: 2026-02-04
• Results posted: 2026-02-04

Locations

57 sites across 10 countries: United States, France, Italy, Mexico, Poland, Romania, Russia, Serbia, Spain, Ukraine

Regulatory

• FDA-regulated drug study