Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
- Registration Number
- NCT00852202
- Lead Sponsor
- Forest Laboratories
- Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- Men and women, 18-65 years old
- Currently meet the DSM-IV-TR criteria for Bipolar I or II Disorder without psychotic features, with a current depressive episode
- A verified previous manic, hypomanic, or mixed episode
- Score of 20 or higher on the HAMD-17
- Score of 2 or higher on Item 1 of the HAMD
- Score greater than 12 on the Young Mania Rating Scale
- Eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months prior to Visit 1
- Principal DSM-IV-TR-based diagnosis of an axis I disorder other than bipolar disorder (a secondary diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or specific phobias is acceptable)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 placebo Matching placebo capsules, oral administration, once daily dosing. 1 cariprazine 0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing. 2 cariprazine 1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing.
- Primary Outcome Measures
Name Time Method Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Baseline to Week 8 The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity.
- Secondary Outcome Measures
Name Time Method Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I ) Baseline to Week 8 The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse.
Trial Locations
- Locations (26)
Forest Investigative Site 026
🇺🇸Orlando, Florida, United States
Forest Investigative Site 005
🇺🇸Encino, California, United States
Forest Investigative Site 006
🇺🇸Media, Pennsylvania, United States
Forest Investigative Site 023
🇺🇸Irving, Texas, United States
Forest Investigative Site 017
🇺🇸Garden Grove, California, United States
Forest Investigative Site 007
🇺🇸Jacksonville, Florida, United States
Forest Investigative Site 024
🇺🇸Glen Burnie, Maryland, United States
Forest Investigative Site 009
🇺🇸Bellevue, Washington, United States
Forest Investigative Site 003
🇺🇸Woodstock, Vermont, United States
Forest Investigative Site 027
🇺🇸National City, California, United States
Forest Investigative Site 001
🇺🇸Bronx, New York, United States
Forest Investigative Site 002
🇺🇸Omaha, Nebraska, United States
Forest Investigative Site 004
🇺🇸Dayton, Ohio, United States
Forest Investigative Site 016
🇺🇸Seattle, Washington, United States
Forest Investigative Site 020
🇺🇸Bradenton, Florida, United States
Forest Investigative Site 018
🇺🇸Durham, North Carolina, United States
Forest Investigative Site 019
🇺🇸Kissimmee, Florida, United States
Forest Investigative Site 011
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative Site 013
🇺🇸Newport Beach, California, United States
Forest Investigative Site 010
🇺🇸Oceanside, California, United States
Forest Investigative Site 012
🇺🇸West Palm Beach, Florida, United States
Forest Investigative Site 029
🇺🇸Creve Coeur, Missouri, United States
Forest Investigative Site 022
🇺🇸Mason, Ohio, United States
Forest Investigative Site 015
🇺🇸Portland, Oregon, United States
Forest Investigative Site 014
🇺🇸Nashville, Tennessee, United States
Forest Investigative Site 028
🇺🇸Cherry Hill, New Jersey, United States