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

NCT ID: NCT00852202

Last Updated: 2018-08-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-06-15

Brief Summary

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

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Detailed Description

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Conditions

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Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing.

Group Type EXPERIMENTAL

cariprazine

Intervention Type DRUG

Drug: cariprazine (0.25 - 0.75 mg/day)

2

1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing.

Group Type EXPERIMENTAL

cariprazine

Intervention Type DRUG

Drug: cariprazine (1.5 - 3.0 mg/day)

3

Matching placebo capsules, oral administration, once daily dosing.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo capsules, oral administration, once daily dosing

Interventions

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cariprazine

Drug: cariprazine (0.25 - 0.75 mg/day)

Intervention Type DRUG

cariprazine

Drug: cariprazine (1.5 - 3.0 mg/day)

Intervention Type DRUG

placebo

placebo capsules, oral administration, once daily dosing

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gedeon Richter Ltd.

INDUSTRY

Sponsor Role collaborator

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Greenberg, MD

Role: STUDY_DIRECTOR

Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

Locations

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Forest Investigative Site 005

Encino, California, United States

Site Status

Forest Investigative Site 017

Garden Grove, California, United States

Site Status

Forest Investigative Site 027

National City, California, United States

Site Status

Forest Investigative Site 013

Newport Beach, California, United States

Site Status

Forest Investigative Site 010

Oceanside, California, United States

Site Status

Forest Investigative Site 020

Bradenton, Florida, United States

Site Status

Forest Investigative Site 007

Jacksonville, Florida, United States

Site Status

Forest Investigative Site 019

Kissimmee, Florida, United States

Site Status

Forest Investigative Site 026

Orlando, Florida, United States

Site Status

Forest Investigative Site 012

West Palm Beach, Florida, United States

Site Status

Forest Investigative Site 024

Glen Burnie, Maryland, United States

Site Status

Forest Investigative Site 029

Creve Coeur, Missouri, United States

Site Status

Forest Investigative Site 002

Omaha, Nebraska, United States

Site Status

Forest Investigative Site 028

Cherry Hill, New Jersey, United States

Site Status

Forest Investigative Site 001

The Bronx, New York, United States

Site Status

Forest Investigative Site 018

Durham, North Carolina, United States

Site Status

Forest Investigative Site 004

Dayton, Ohio, United States

Site Status

Forest Investigative Site 022

Mason, Ohio, United States

Site Status

Forest Investigative Site 015

Portland, Oregon, United States

Site Status

Forest Investigative Site 006

Media, Pennsylvania, United States

Site Status

Forest Investigative Site 011

Philadelphia, Pennsylvania, United States

Site Status

Forest Investigative Site 014

Nashville, Tennessee, United States

Site Status

Forest Investigative Site 023

Irving, Texas, United States

Site Status

Forest Investigative Site 003

Woodstock, Vermont, United States

Site Status

Forest Investigative Site 009

Bellevue, Washington, United States

Site Status

Forest Investigative Site 016

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Earley WR, Burgess M, Rekeda L, Hankinson A, McIntyre RS, Suppes T, Calabrese JR, Yatham LN. A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression. J Affect Disord. 2020 Feb 15;263:386-395. doi: 10.1016/j.jad.2019.11.098. Epub 2019 Nov 22.

Reference Type DERIVED
PMID: 31969269 (View on PubMed)

Other Identifiers

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RGH-MD-52

Identifier Type: -

Identifier Source: org_study_id

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