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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: Completed Phase 2 study of Depression, Bipolar, sponsored by Forest Laboratories.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scor
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 |
What the finished NCT01396447 record still lists
NCT01396447 is an interventional study that assigns participants to a tested intervention. The registered 584 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 612-participant average among 5 other Depression, Bipolar trials with a reported enrollment target.
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 names 20 study sites across 12 states, led by 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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