At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,944 enrolled
Drug / intervention
OPC-34712 +6 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 Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted May 26, 2011·Updated Sep 17, 2018
In Brief
A Phase 3 clinical trial evaluating OPC-34712, Escitalopram, and 5 other interventions for Depressive Disorder and 4 related conditions. Completed, enrolled 2,944 participants across 142 sites in 11 countries.
Detailed Summary
To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
CountriesCanada, France, Germany, Hungary, Poland, Romania, Russia, Serbia, Slovakia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartOct 2011
Primary CompletionApr 2017
Study CompletionMay 2017
TodayJul 2026
First PostedMay 26, 2011
Enrollment StartOct 1, 2011
Primary CompletionApr 18, 2017
Study CompletionMay 18, 2017
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 15.1 years ago
Interventions
OPC-34712drug
Tablet
Escitalopramdrug
Tablet
Fluoxetinedrug
Capsule
Paroxetine CRdrug
Controlled-release tablets
Sertralinedrug
Tablets
Duloxetinedrug
Delayed-release capsules
Venlafaxine XRdrug
Extended-release capsules