At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 773 enrolled
Drug / intervention
OPC-34712 +2 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, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPDC-34712 (1 to 3 mg/Day) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder.
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jan 20, 2010·Updated Nov 2, 2015
In Brief
A Phase 2 clinical trial evaluating OPC-34712, Placebo, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 773 participants across 43 sites.
Detailed Summary
This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2010
Enrollment StartMar 2010
Primary CompletionOct 2011
Study CompletionNov 2011
TodayJul 2026
First PostedJan 20, 2010
Enrollment StartMar 1, 2010
Primary CompletionOct 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.4 years ago
Interventions
OPC-34712drug
Tablets, Oral, 1 - 3 mg OPC-34712
Placebodrug
Placebo
ADTdrug