Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
Public ClinicalTrials.gov record NCT01360632. 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 Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Two Fixed Doses of OPDC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Polaris 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
- NCT01360632
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,539 participants
Conditions and interventions
Conditions
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 2011 (Type not available)
- Primary completion
- Aug 2013 (Actual)
- Completion
- Sep 2013 (Actual)
- Last update posted
- Jan 1, 2016
2011 – 2013
United States locations
- U.S. sites
- 52
- U.S. states
- 26
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | — | — |
| Research Site | Costa Mesa | California | — | — |
| Research Site | Glendale | California | — | — |
| Research Site | Orange | California | — | — |
| Research Site | San Diego | California | — | — |
| Research Site | Temecula | California | — | — |
| Research Site | Jacksonville | Florida | — | — |
| Research Site | Jacksonville Beach | Florida | — | — |
| Research Site | Miami Springs | Florida | — | — |
| Research Site | Tampa | Florida | — | — |
| Research Site | Winter Park | Florida | — | — |
| Research Site | Atlanta | Georgia | — | — |
| Research Site | Smyrna | Georgia | — | — |
| Research Site | Chicago | Illinois | — | — |
| Research Site | Oak Brook | Illinois | — | — |
| Research Site | Lafayette | Indiana | — | — |
| Research Site | Owensboro | Kentucky | — | — |
| Research Site | Baltimore | Maryland | — | — |
| Research Site | Haverhill | 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 | Toms River | New Jersey | — | — |
| Research Site | Brooklyn | New York | — | — |
| Research Site | Fresh Meadows | New York | — | — |
| Research Site | New York | New York | — | — |
| Research Site | Staten Island | New York | — | — |
| Research Site | Raleigh | North Carolina | — | — |
| Research Site | Beachwood | Ohio | — | — |
| Research Site | Cincinnati | Ohio | — | — |
| Research Site | Columbus | Ohio | — | — |
| Research Site | Oklahoma City | Oklahoma | — | — |
| Research Site | Portland | Oregon | — | — |
| Not listed | Salem | Oregon | — | — |
| Research Site | Norristown | Pennsylvania | — | — |
| Research Site | Philadelphia | Pennsylvania | — | — |
| Research Site | Lincoln | Rhode Island | — | — |
| Research Site | Columbia | South Carolina | — | — |
| Research Site | Memphis | Tennessee | — | — |
| Research Site | Austin | Texas | — | — |
| Research Site | Dallas | Texas | — | — |
| Research Site | Houston | Texas | — | — |
| Research Site | San Antonio | Texas | — | — |
| Research Site | Witchita Falls | Texas | — | — |
| Research Site | Charlottesville | Virginia | — | — |
| Research Site | Herndon | Virginia | — | — |
| Research Site | Bellevue | 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 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01360632, 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 Jan 1, 2016 · Synced Oct 18, 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 NCT01360632 live on ClinicalTrials.gov.