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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 Jul 24, 2026, 5:48 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

Study identification

NCT ID
NCT01360645
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
826 participants

Conditions and interventions

Interventions

  • OPC-34712 + 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, 2011
Primary completion
Apr 30, 2013
Completion
May 31, 2013
Last update posted
Nov 25, 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 25, 2015 · Synced Jul 24, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01360645 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →