At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 295 enrolled
Drug / intervention
Brexpiprazoledrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Aug 3, 2017·Updated Feb 4, 2026
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole for Schizophrenia. Completed, enrolled 295 participants across 57 sites in 10 countries.
Detailed Summary
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesFrance, Italy, Mexico, Poland, Romania, Russia, Serbia, Spain, Ukraine, United States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartAug 2017
Primary CompletionApr 2025
TodayJul 2026
First PostedAug 3, 2017
Enrollment StartAug 23, 2017
Primary CompletionApr 22, 2025
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 8.9 years ago
Interventions
Brexpiprazoledrug
Once daily, oral tablets