Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)
Study identification
- NCT ID
- NCT01360866
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,944 participants
Conditions and interventions
Conditions
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
- Oct 2011 (Actual)
- Primary completion
- Apr 18, 2017 (Actual)
- Completion
- May 18, 2017 (Actual)
- Last update posted
- Sep 17, 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 17, 2018 · Synced Oct 28, 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 public registry record, listed eligibility criteria, and available contact information for NCT01360866 live on ClinicalTrials.gov.