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Completed Phase 3 Interventional Results available

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.

ClinicalTrials.gov public records Last synced Nov 10, 2026, 10:04 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress

Study identification

NCT ID
NCT02196506
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
837 participants

Conditions and interventions

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
Jul 2014 (Type not available)
Primary completion
Apr 2016 (Actual)
Completion
May 2016 (Actual)
Last update posted
Aug 21, 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 21, 2018 · Synced Nov 10, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02196506 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →