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

This study has been completed.
Gedeon Richter Ltd.
Information provided by:
Forest Laboratories Identifier:
First received: February 25, 2009
Last updated: July 6, 2011
Last verified: July 2011
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Clinical Global Impression - Improvement (CGI-I) [ Time Frame: 8 weeks ]

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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00852202

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

Responsible Party: William Greenberg, MD, Associate Director, Forest Research Institute, a subsidiary of Forest Laboratories, Inc. Identifier: NCT00852202     History of Changes
Other Study ID Numbers: RGH-MD-52
Study First Received: February 25, 2009
Last Updated: July 6, 2011

Keywords provided by Forest Laboratories:

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders processed this record on May 25, 2017