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NCT01396447 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
A Phase 2 study of Depression, Bipolar, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 584
- Enrollment target
- 20
- Study locations
NCT01396447 is a Phase 2 study of Depression, Bipolar that has completed, run by Forest Laboratories. The registered enrollment target is 584 participants, roughly in line with the 612-participant average among 5 other Depression, Bipolar trials with a reported enrollment target. The trial reports 20 study locations across 12 states.
The verdict
NCT01396447, a Phase 2 study of Depression, Bipolar, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 584 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cariprazine
Study Locations (20)
California
- Forest Investigative Site 030 - Beverly Hills
- Forest Investigative Site 018 - Cerritos
- Forest Investigative Site 028 - Costa Mesa
- Forest Investigative Site 015 - Oceanside
- Forest Investigative Site 011 - Temecula
Florida
- Forest Investigative Site 012 - Jacksonville
- Forest Investigative Site 035 - Orlando
- Forest Investigative Site 013 - Winter Park
Georgia
- Forest Investigative Site 038 - Atlanta
- Forest Investigative Site 005 - Atlanta
Louisiana
- Forest Investigative Site 041 - Lake Charles
- Forest Investigative Site 040 - Shreveport
Alabama
- Forest Investigative Site 021 - Birmingham
Arkansas
- Forest Investigative Site 017 - Springdale
Illinois
- Forest Investigative Site 029 - Chicago
Indiana
- Forest Investigative Site 024 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 584 participants |
| Start Date | 2011-07-26 |
| Est. Completion | 2014-01-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01396447
The ClinicalTrials.gov registry entry for NCT01396447 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 584 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 612-participant average among 5 other Depression, Bipolar trials with a reported enrollment target. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Depression, Bipolar appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01396447 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01396447 about?
NCT01396447 is a clinical study titled "Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression". The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.
What is the current status of trial NCT01396447?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 584 participants. The study started on 2011-07-26. Estimated completion is 2014-01-10.
What conditions does trial NCT01396447 study?
This clinical trial studies the following conditions: Depression, Bipolar.
What interventions are being tested in trial NCT01396447?
The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG).
Who is sponsoring clinical trial NCT01396447?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01396447 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, 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.