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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00852202
Recruitment Status : Completed
First Posted : February 26, 2009
Results First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: cariprazine Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression
Actual Study Start Date : June 30, 2009
Actual Primary Completion Date : June 15, 2010
Actual Study Completion Date : June 15, 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 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 :
  1. Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I ) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852202


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

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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00852202     History of Changes
Other Study ID Numbers: RGH-MD-52
First Posted: February 26, 2009    Key Record Dates
Results First Posted: August 23, 2018
Last Update Posted: August 23, 2018
Last Verified: August 2018

Keywords provided by Forest Laboratories:
bipolar
depression

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Cariprazine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs