Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress

ClinicalTrials.gov ID: NCT02196506

Public ClinicalTrials.gov record NCT02196506. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 5, 2026, 5:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress

Study identification

NCT ID: NCT02196506
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Industry
Enrollment: 837 participants

Conditions and interventions

Conditions

Interventions

Brexpiprazole +ADT Drug
Placebo + ADT Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 30, 2014
Primary completion: Mar 31, 2016
Completion: Apr 30, 2016
Last update posted: Aug 20, 2018

2014 – 2016

United States locations

U.S. sites: 30
U.S. states: 23
U.S. cities: 30

Facility	City	State	ZIP	Site status
Not listed	Birmingham	Alabama	—	—
Not listed	Beverly Hills	California	—	—
Not listed	Denver	Colorado	—	—
Not listed	Hialeah	Florida	—	—
Not listed	Orlando	Florida	—	—
Not listed	Alpharetta	Georgia	—	—
Not listed	Smyrna	Georgia	—	—
Not listed	Baltimore	Maryland	—	—
Not listed	Boston	Massachusetts	—	—
Not listed	Rochester Hills	Michigan	—	—
Not listed	Cherry Hill	New Jersey	—	—
Not listed	Jamaica	New York	—	—
Not listed	New York	New York	—	—
Not listed	Staten Island	New York	—	—
Not listed	Raleigh	North Carolina	—	—
Not listed	Cincinnati	Ohio	—	—
Not listed	Edmond	Oklahoma	—	—
Not listed	Portland	Oregon	—	—
Not listed	Salem	Oregon	—	—
Not listed	Philadelphia	Pennsylvania	—	—
Not listed	Lincoln	Rhode Island	—	—
Not listed	Columbia	South Carolina	—	—
Not listed	Memphis	Tennessee	—	—
Not listed	Wichita Falls	Texas	—	—
Not listed	Murray	Utah	—	—
Not listed	Woodstock	Vermont	—	—
Not listed	Charlottesville	Virginia	—	—
Not listed	Richmond	Virginia	—	—
Not listed	Seattle	Washington	—	—
Not listed	Spokane	Washington	—	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02196506, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 20, 2018 · Synced May 5, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02196506 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →