At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 316 enrolled
Drug / intervention
Brexpiprazole (OPC-34712) +2 moredrug
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 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
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jun 23, 2017·Updated Dec 20, 2023
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole (OPC-34712), Aripiprazole, and 1 other intervention for Schizophrenia. Completed, enrolled 316 participants across 1 site.
Detailed Summary
To determine the safety \& efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartJun 2017
Primary CompletionApr 2023
TodayJul 2026
First PostedJun 23, 2017
Enrollment StartJun 30, 2017
Primary CompletionApr 3, 2023
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 9.0 years ago
Interventions
Brexpiprazole (OPC-34712)drug
Once-daily, tablets
Aripiprazoledrug
Once-daily, tablets
Placebodrug
Once-daily, tablets