CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,539 enrolled
Drug / intervention
OPC-34712 + ADT +2 moredrug
Likely dose
OPC-34712 + ADT 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.

Search/NCT01360632
NCT01360632Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Two Fixed Doses of OPDC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Polaris Trial

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted May 25, 2011·Updated Jan 1, 2016

In Brief

A Phase 3 clinical trial evaluating OPC-34712 + ADT and Placebo + ADT for Depressive Disorder and 4 related conditions. Completed, enrolled 1,539 participants across 71 sites in 7 countries.

Detailed Summary

To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
CountriesCanada, Germany, Hungary, Romania, Russia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2011
Enrollment StartJun 1, 2011
Primary CompletionAug 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.1 years ago

Interventions

OPC-34712 + ADTdrug

Tablets, Oral, 1 or 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT)

Placebo + ADTdrug

Placebo + FDA Approved Antidepressant (ADT)

Placebo + ADTdrug

Placebo + FDA Approved Antidepressant (ADT)