At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 850 enrolled
Drug / intervention
OPC-34712 +2 moredrug
Likely dose
OPC-34712 4 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, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Nov 25, 2008·Updated Feb 29, 2016
In Brief
A Phase 2 clinical trial evaluating OPC-34712, Placebo, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 850 participants across 50 sites.
Detailed Summary
Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed ADT.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartMay 2009
Primary CompletionJun 2010
Study CompletionJul 2010
TodayJul 2026
First PostedNov 25, 2008
Enrollment StartMay 1, 2009
Primary CompletionJun 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.6 years ago
Interventions
OPC-34712drug
Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks
Placebodrug
Tablets, Oral, 1- 4 mg OPC-34712 once daily, 14 weeks
ADTdrug
Tablets, 10 - 225 mgs, dose once daily, 14 weeks