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

August 22, 2018 updated by: Forest Laboratories

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encino, California, United States, 91316
        • Forest Investigative Site 005
      • Garden Grove, California, United States, 92845
        • Forest Investigative Site 017
      • National City, California, United States, 91950
        • Forest Investigative Site 027
      • Newport Beach, California, United States, 92660
        • Forest Investigative Site 013
      • Oceanside, California, United States, 92056
        • Forest Investigative Site 010
    • Florida
      • Bradenton, Florida, United States, 34208
        • Forest Investigative Site 020
      • Jacksonville, Florida, United States, 32216
        • Forest Investigative Site 007
      • Kissimmee, Florida, United States, 34741
        • Forest Investigative Site 019
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site 026
      • West Palm Beach, Florida, United States, 33407
        • Forest Investigative Site 012
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Forest Investigative Site 024
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Forest Investigative Site 029
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Forest Investigative Site 002
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Forest Investigative Site 028
    • New York
      • Bronx, New York, United States, 10467
        • Forest Investigative Site 001
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Forest Investigative Site 018
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Forest Investigative Site 004
      • Mason, Ohio, United States, 45040
        • Forest Investigative Site 022
    • Oregon
      • Portland, Oregon, United States, 97210
        • Forest Investigative Site 015
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Forest Investigative Site 006
      • Philadelphia, Pennsylvania, United States, 19107
        • Forest Investigative Site 011
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Forest Investigative Site 014
    • Texas
      • Irving, Texas, United States, 75062
        • Forest Investigative Site 023
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Forest Investigative Site 003
    • Washington
      • Bellevue, Washington, United States, 98004
        • Forest Investigative Site 009
      • Seattle, Washington, United States, 98104
        • Forest Investigative Site 016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)
Drug: cariprazine
Drug: cariprazine (1.5 - 3.0 mg/day)
Experimental: 2
1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing.
Drug: cariprazine
Drug: cariprazine (0.25 - 0.75 mg/day)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Collaborators

Gedeon Richter Ltd.

Investigators

  • Study Director: William Greenberg, MD, Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2009

Primary Completion (Actual)

June 15, 2010

Study Completion (Actual)

June 15, 2010

Study Registration Dates

First Submitted

February 25, 2009

First Submitted That Met QC Criteria

February 25, 2009

First Posted (Estimate)

February 26, 2009

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGH-MD-52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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