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Completed Phase 3 Interventional Results available

Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)

ClinicalTrials.gov ID: NCT01360866

Public ClinicalTrials.gov record NCT01360866. 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 23, 2026, 1:26 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 Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial

Study identification

NCT ID
NCT01360866
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
2,944 participants

Conditions and interventions

Interventions

  • OPC-34712 Drug
  • Escitalopram Drug
  • Fluoxetine Drug
  • Paroxetine CR Drug
  • Sertraline Drug
  • Duloxetine Drug
  • Venlafaxine XR 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
Sep 30, 2011
Primary completion
Apr 17, 2017
Completion
May 17, 2017
Last update posted
Sep 16, 2018

2011 – 2017

United States locations

U.S. sites
93
U.S. states
32
U.S. cities
93
Facility City State ZIP Site status
Research Site Birmingham Alabama
Research Site Phoenix Arizona
Research Site Little Rock Arkansas
Research Site Beverly Hills California
Research Site Costa Mesa California
Research Site Glendale California
Research Site Irvine California
Research Site Oceanside California
Research Site Redlands California
Research Site San Diego California
Research Site San Francisco California
Research Site Santa Ana California
Research Site Sherman Oaks California
Research Site Temecula California
Research Site Upland California
Research Site Norwalk Connecticut
Research Site Coral Gables Florida
Research Site Coral Springs Florida
Research Site Fort Myers Florida
Research Site Gainesville Florida
Research Site Hialeah Florida
Research Site Jacksonville Florida
Research Site Jacksonville Beach Florida
Research Site Melbourne Florida
Research Site Miami Florida
Research Site Miami Springs Florida
Research Site Oakland Park Florida
Research Site Orlando Florida
Research Site The Villages Florida
Research Site Winter Park Florida
Research Site Alpharetta Georgia
Research Site Atlanta Georgia
Research Site Decatur Georgia
Research Site Smyrna Georgia
Research Site Oak Brook Illinois
Research Site Indianapolis Indiana
Research Site Lafayette Indiana
Research Site Prairie Village Kansas
Research Site Wichita Kansas
Research Site Lake Charles Louisiana
Research Site New Orleans Louisiana
Research Site Shreveport Louisiana
Research Site Baltimore Maryland
Research Site Belmont Massachusetts
Research Site Boston Massachusetts
Research Site Methuen Massachusetts
Research Site Watertown Massachusetts
Research Site Weymouth Massachusetts
Research Site Rochester Hills Michigan
Research Site Creve Coeur Missouri
Research Site Las Vegas Nevada
Research Site Cherry Hill New Jersey
Research Site Tom River New Jersey
Research Site Brooklyn New York
Research Site Jamaica New York
Research Site New York New York
Research Site Rochester New York
Research Site Staten Island New York
Research Site Raleigh North Carolina
Research Site Wilmington North Carolina
Research Site Beachwood Ohio
Research Site Cincinnati Ohio
Research Site Columbus Ohio
Research Site Dayton Ohio
Research Site Toledo Ohio
Research Site Oklahoma City Oklahoma
Research Site Portland Oregon
Research Site Salem Oregon
Research Site Allentown Pennsylvania
Research Site Bala-Cynwyd Pennsylvania
Research Site Bridgeville Pennsylvania
Research Site Norristown Pennsylvania
Research Site Philadelphia Pennsylvania
Research Site Lincoln Rhode Island
Research Site Columbia South Carolina
Research Site Memphis Tennessee
Research Site Arlington Texas
Research Site Austin Texas
Research Site Dallas Texas
Research Site Houston Texas
Research Site San Antonio Texas
Research Site Wichita Falls Texas
Research Site Murray Utah
Research Site Woodstock Vermont
Research Site Charlottesville Virginia
Research Site Herndon Virginia
Research Site Richmond Virginia
Research Site Bellevue Washington
Research Site Kirkland Washington
Research Site Seattle Washington
Research Site Spokane Washington
Research Site Brown Deer Wisconsin
Research Site Middleton Wisconsin

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 49 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01360866, 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 Sep 16, 2018 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01360866 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →