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Completed Phase 3 Interventional Results available

Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial)

ClinicalTrials.gov ID: NCT01360645

Public ClinicalTrials.gov record NCT01360645. 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 Oct 30, 2026, 3:47 AM 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 OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Pyxis Trial

Brief summary

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

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 identification

NCT ID
NCT01360645
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
826 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 2011 (Type not available)
Primary completion
May 2013 (Actual)
Completion
Jun 2013 (Actual)
Last update posted
Nov 26, 2015

2011 – 2013

United States locations

U.S. sites
37
U.S. states
18
U.S. cities
37
Facility City State ZIP Site status
Research Site Arcadia California — —
Research Site Beverly Hills California — —
Research Site Fresno California — —
Research Site Oceanside California — —
Research Site San Diego California — —
Research Site San Francisco California — —
Research Site Sherman Oaks California — —
Research Site Denver Colorado — —
Research Site Norwalk Connecticut — —
Research Site Coral Springs Florida — —
Research Site Fort Myers Florida — —
Research Site Hialeah Florida — —
Research Site Jacksonville Florida — —
Research Site Melbourne Florida — —
Research Site Orlando Florida — —
Research Site Indianapolis Indiana — —
Research Site Prairie Village Kansas — —
Research Site Wichita Kansas — —
Research Site New Orleans Louisiana — —
Research Site Shreveport Louisiana — —
Research Site Belmont Massachusetts — —
Research Site Boston Massachusetts — —
Research Site Lincoln Nebraska — —
Research Site New York New York — —
Research Site Rochester New York — —
Research Site Dayton Ohio — —
Research Site Toledo Ohio — —
Research Site Salem Oregon — —
Research Site Allentown Pennsylvania — —
Research Site Bala-Cynwyd Pennsylvania — —
Research Site Bridgeville Pennsylvania — —
Research Site Philadelphia Pennsylvania — —
Research Site San Antonio Texas — —
Research Site Murray Utah — —
Research Site Woodstock Vermont — —
Research Site Richmond Virginia — —
Research Site Seattle 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 20 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01360645, 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 Nov 26, 2015 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01360645 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →