Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
Public ClinicalTrials.gov record NCT02670551. 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 investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (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
- NCT02670551
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 488 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 17, 2016 (Actual)
- Primary completion
- Jul 19, 2017 (Actual)
- Completion
- Jul 19, 2017 (Actual)
- Last update posted
- Jan 30, 2019
2016 – 2017
United States locations
- U.S. sites
- 44
- U.S. states
- 19
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Psychiatric Clinic Clinical Research Trials PA | Little Rock | Arkansas | 72211 | — |
| ATP Clinical Research, Inc. | Costa Mesa | California | 92626 | — |
| Synergy San Diego | Escondido | California | 92025 | — |
| Integrated Medical and Behavioral Associates | Glendale | California | 91204 | — |
| Apostle Clinical Trials, Inc. | Long Beach | California | 90813 | — |
| Pacific Research Partners, LLC | Oakland | California | 94612 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | — |
| Viking Clinical Research | Temecula | California | 92591 | — |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | — |
| Comprehensive Psychiatric Care | Norwich | Connecticut | 06360 | — |
| CNS Healthcare | Jacksonville | Florida | 32256 | — |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32801 | — |
| Olympian Clinical Research | Tampa | Florida | 33609 | — |
| Radiant Research | Atlanta | Georgia | 30328 | — |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | — |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | — |
| Carman Research | Smyrna | Georgia | 30080 | — |
| Psychiatric Medicine Associates, L.L.C | Skokie | Illinois | 60076 | — |
| Neuroscience Research Institute Inc. | Winfield | Illinois | 60190 | — |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63304 | — |
| Altea Research Institute | Las Vegas | Nevada | 89102 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | — |
| Medical & Behavioral Health Research, PC | New York | New York | 10023 | — |
| Neuro-Behavioral Clinical Research | Canton | Ohio | 44718 | — |
| Patient Priority Clinical Sites | Cincinnati | Ohio | 45215 | — |
| Ohio State University Department of Psychiatry | Columbus | Ohio | 43210 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Oregon Center for Clinical Investigations, Inc. | Portland | Oregon | 97214 | — |
| Oregon Center for Clinical Investigations | Salem | Oregon | 97301 | — |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | — |
| Lincoln Research, LLC | Lincoln | Rhode Island | 02865 | — |
| Clinical Neuroscience Solutions | Memphis | Tennessee | 38119 | — |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | — |
| Houston Clinical Trials, LLC | Houston | Texas | 77098 | — |
| Research Across America | Plano | Texas | 75093 | — |
| Family Psychiatry of The Woodlands | The Woodlands | Texas | 77381 | — |
| Alliance Research Group | Richmond | Virginia | 23230 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
| Core Clinical Research | Kirkland | Washington | 98033 | — |
| Summit Research Network Seattle | Seattle | Washington | 98104 | — |
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 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02670551, 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 30, 2019 · Synced Oct 21, 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 NCT02670551 live on ClinicalTrials.gov.