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

Bipolar Depression Clinical Trial

Official title:

A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852202
• Other study ID #: RGH-MD-52
• Status: Completed
• Phase: Phase 2
• Start date: June 30, 2009
• Est. completion date: June 15, 2010

Study information

• Verified date: August 2018
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: June 15, 2010
• Est. primary completion date: June 15, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• cariprazine
Drug: cariprazine (0.25 - 0.75 mg/day)
• cariprazine
Drug: cariprazine (1.5 - 3.0 mg/day)
• placebo
placebo capsules, oral administration, once daily dosing

Locations

Country	Name	City	State
United States	Forest Investigative Site 009	Bellevue	Washington
United States	Forest Investigative Site 020	Bradenton	Florida
United States	Forest Investigative Site 001	Bronx	New York
United States	Forest Investigative Site 028	Cherry Hill	New Jersey
United States	Forest Investigative Site 029	Creve Coeur	Missouri
United States	Forest Investigative Site 004	Dayton	Ohio
United States	Forest Investigative Site 018	Durham	North Carolina
United States	Forest Investigative Site 005	Encino	California
United States	Forest Investigative Site 017	Garden Grove	California
United States	Forest Investigative Site 024	Glen Burnie	Maryland
United States	Forest Investigative Site 023	Irving	Texas
United States	Forest Investigative Site 007	Jacksonville	Florida
United States	Forest Investigative Site 019	Kissimmee	Florida
United States	Forest Investigative Site 022	Mason	Ohio
United States	Forest Investigative Site 006	Media	Pennsylvania
United States	Forest Investigative Site 014	Nashville	Tennessee
United States	Forest Investigative Site 027	National City	California
United States	Forest Investigative Site 013	Newport Beach	California
United States	Forest Investigative Site 010	Oceanside	California
United States	Forest Investigative Site 002	Omaha	Nebraska
United States	Forest Investigative Site 026	Orlando	Florida
United States	Forest Investigative Site 011	Philadelphia	Pennsylvania
United States	Forest Investigative Site 015	Portland	Oregon
United States	Forest Investigative Site 016	Seattle	Washington
United States	Forest Investigative Site 012	West Palm Beach	Florida
United States	Forest Investigative Site 003	Woodstock	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Gedeon Richter Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)	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.	Baseline to Week 8
Secondary	Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I )	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.	Baseline to Week 8