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NCT02670551 · ClinicalTrials.gov registry record · Phase 3
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
A Phase 3 study of Depression and Bipolar Disorder, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 488
- Enrollment target
- 20
- Study locations
NCT02670551 is a Phase 3 study of Depression and Bipolar Disorder that has completed, run by Forest Laboratories. The registered enrollment target is 488 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT02670551, a Phase 3 study of Depression and Bipolar Disorder, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 488 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cariprazine
Study Locations (20)
California
- ATP Clinical Research, Inc. - Costa Mesa
- Synergy San Diego - Escondido
- Integrated Medical and Behavioral Associates - Glendale
- Apostle Clinical Trials, Inc. - Long Beach
- Pacific Research Partners, LLC - Oakland
- Artemis Institute for Clinical Research - San Diego
- Schuster Medical Research Institute - Sherman Oaks
- Viking Clinical Research - Temecula
- Pacific Clinical Research Medical Group - Upland
Georgia
- Radiant Research - Atlanta
- iResearch Atlanta, LLC - Decatur
- Northwest Behavioral Research Center - Marietta
- Carman Research - Smyrna
Florida
- CNS Healthcare - Jacksonville
- Clinical Neuroscience Solutions, Inc - Orlando
- Olympian Clinical Research - Tampa
Illinois
- Psychiatric Medicine Associates, L.L.C - Skokie
- Neuroscience Research Institute Inc. - Winfield
Arkansas
- Arkansas Psychiatric Clinic Clinical Research Trials PA - Little Rock
Connecticut
- Comprehensive Psychiatric Care - Norwich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2016-03-17 |
| Est. Completion | 2017-07-19 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02670551
The ClinicalTrials.gov registry entry for NCT02670551 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 488 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (38% lower). The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02670551 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Georgia, Florida.
Frequently Asked Questions
What is clinical trial NCT02670551 about?
NCT02670551 is a clinical study titled "Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression". 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.
What is the current status of trial NCT02670551?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 488 participants. The study started on 2016-03-17. Estimated completion is 2017-07-19.
What conditions does trial NCT02670551 study?
This clinical trial studies the following conditions: Depression, Bipolar Disorder.
What interventions are being tested in trial NCT02670551?
The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG).
Who is sponsoring clinical trial NCT02670551?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02670551 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.