Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder
Public ClinicalTrials.gov record NCT02670538. 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, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
Study identification
- NCT ID
- NCT02670538
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 493 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
- Mar 31, 2016 (Actual)
- Primary completion
- Jan 18, 2018 (Actual)
- Completion
- Jan 18, 2018 (Actual)
- Last update posted
- Mar 12, 2019
2016 – 2018
United States locations
- U.S. sites
- 42
- U.S. states
- 20
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Harmonex Neuroscience Research, Inc. | Dothan | Alabama | 36303 | — |
| NoesisPharma, LLC | Phoenix | Arizona | 85032 | — |
| Woodland International Research Group, LLC | Little Rock | Arkansas | 72211 | — |
| Advanced Research Center, Inc | Anaheim | California | 92805 | — |
| Radiant Research | Cerritos | California | 90703 | — |
| Collaborative Neuroscience Network, LLC | Garden Grove | California | 92845 | — |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | — |
| Excell Research, Inc. | Oceanside | California | 92056 | — |
| Collaborative Neuroscience Network, LLC | Torrance | California | 90502 | — |
| Comprehensive Clinical Research | Washington D.C. | District of Columbia | 20016 | — |
| CNS Clinical Research Group | Coral Springs | Florida | 33067 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| Innovative Clinical Research, Inc. | Lauderhill | Florida | 33319 | — |
| Innova Clinical Trials, Inc. | Miami | Florida | 33133 | — |
| Research Centers of America, LLC | Oakland Park | Florida | 33334 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | — |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | — |
| Baber Research Group | Naperville | Illinois | 60563 | — |
| J. Gary Booker, MD, APMC | Shreveport | Louisiana | 71104 | — |
| Coastal Research Associates, Inc. | Weymouth | Massachusetts | 02190 | — |
| Millennium Psychiatric Associates | Creve Coeur | Missouri | 63141 | — |
| St. Louis Clinical Trials, LLC | St Louis | Missouri | 63141 | — |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | — |
| Pharmaceutical Research Associates, Inc. | Marlton | New Jersey | 08053 | — |
| Brooklyn Medical Institute | Brooklyn | New York | 11214 | — |
| SPRI Clinical Trials, LLC | Brooklyn | New York | 11235 | — |
| University at Buffalo Erie County Medical Center | Buffalo | New York | 14215 | — |
| Manhattan Behavioral Medicine | New York | New York | 10036 | — |
| Eastside Comprehensive Medical Center | New York | New York | 10128 | — |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | — |
| Clinical Trials of America, Inc | Hickory | North Carolina | 28601 | — |
| University of Cincinnati - Department of Psychiatry and Behavioral Neuroscience | Cincinnati | Ohio | 45219 | — |
| Professional Psychiatric Services | Mason | Ohio | 45040 | — |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | — |
| Tulsa Clinical Research, LLC | Tulsa | Oklahoma | 74104 | — |
| Suburban Research Associates | Media | Pennsylvania | 19063 | — |
| Carolina Clinical Trials, Inc. | Charleston | South Carolina | 29407 | — |
| Houston Endoscopy and Research Center | Houston | Texas | 77079 | — |
| Grayline Research Center | Wichita Falls | Texas | 76309 | — |
| Pacific Institute of Medical Sciences | Bothell | Washington | 98011 | — |
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 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02670538, 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 Mar 12, 2019 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02670538 live on ClinicalTrials.gov.