At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,036 enrolled
Drug / intervention
ADT +1 moredrug
Likely dose
OPC-34712 3 mgfrom 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 Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adult Patients With Major Depressive Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Oct 6, 2011·Updated Nov 6, 2015
In Brief
A Phase 2 clinical trial evaluating ADT and OPC-34712 for Major Depressive Disorder. Completed, enrolled 1,036 participants across 32 sites.
Detailed Summary
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedOct 2011
Primary CompletionDec 2012
TodayJul 2026
First PostedOct 6, 2011
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.7 years ago
Interventions
ADTdrug
Once daily dosing during the duration of the study.
OPC-34712drug
OPC-34712, Oral Tablets, 0.25 - 3 mg