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Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00852202
First received: February 25, 2009
Last updated: July 6, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.


Condition Intervention Phase
Bipolar Depression
 Drug: cariprazine
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression - Improvement (CGI-I) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 234
Study Start Date: June 2009
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing.
 Drug: cariprazine
Drug: cariprazine (0.25 - 0.75 mg/day)
Experimental: 2
1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing.
 Drug: cariprazine
Drug: cariprazine (1.5 - 3.0 mg/day)
Placebo Comparator: 3
Matching placebo capsules, oral administration, once daily dosing.
 Drug: placebo
placebo capsules, oral administration, once daily dosing

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852202

  Show 26 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: William Greenberg, MD Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
  More Information

No publications provided

Responsible Party: William Greenberg, MD, Associate Director, Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00852202     History of Changes
Other Study ID Numbers: RGH-MD-52
Study First Received: February 25, 2009
Last Updated: July 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
bipolar
depression

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
 Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 16, 2013