search
Back to results

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

Primary Purpose

Bipolar Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cariprazine
cariprazine
placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring bipolar, depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Forest Investigative Site 005
  • Forest Investigative Site 017
  • Forest Investigative Site 027
  • Forest Investigative Site 013
  • Forest Investigative Site 010
  • Forest Investigative Site 020
  • Forest Investigative Site 007
  • Forest Investigative Site 019
  • Forest Investigative Site 026
  • Forest Investigative Site 012
  • Forest Investigative Site 024
  • Forest Investigative Site 029
  • Forest Investigative Site 002
  • Forest Investigative Site 028
  • Forest Investigative Site 001
  • Forest Investigative Site 018
  • Forest Investigative Site 004
  • Forest Investigative Site 022
  • Forest Investigative Site 015
  • Forest Investigative Site 006
  • Forest Investigative Site 011
  • Forest Investigative Site 014
  • Forest Investigative Site 023
  • Forest Investigative Site 003
  • Forest Investigative Site 009
  • Forest Investigative Site 016

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

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

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

Matching placebo capsules, oral administration, once daily dosing.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 25, 2009
Last Updated
August 22, 2018
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00852202
Brief Title
Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
Official Title
A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 30, 2009 (Actual)
Primary Completion Date
June 15, 2010 (Actual)
Study Completion Date
June 15, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
bipolar, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing.
Arm Title
2
Arm Type
Experimental
Arm Description
1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing.
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Matching placebo capsules, oral administration, once daily dosing.
Intervention Type
Drug
Intervention Name(s)
cariprazine
Intervention Description
Drug: cariprazine (0.25 - 0.75 mg/day)
Intervention Type
Drug
Intervention Name(s)
cariprazine
Intervention Description
Drug: cariprazine (1.5 - 3.0 mg/day)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo capsules, oral administration, once daily dosing
Primary Outcome Measure Information:
Title
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I )
Description
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.
Time Frame
Baseline to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Greenberg, MD
Organizational Affiliation
Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 005
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Forest Investigative Site 017
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Forest Investigative Site 027
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Forest Investigative Site 013
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Forest Investigative Site 010
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 020
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Forest Investigative Site 007
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Forest Investigative Site 019
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Forest Investigative Site 026
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 012
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Forest Investigative Site 024
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Forest Investigative Site 029
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 002
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Forest Investigative Site 028
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Forest Investigative Site 001
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Forest Investigative Site 018
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Forest Investigative Site 004
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Forest Investigative Site 022
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Forest Investigative Site 015
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Forest Investigative Site 006
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Forest Investigative Site 011
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Forest Investigative Site 014
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Forest Investigative Site 023
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Forest Investigative Site 003
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
Forest Investigative Site 009
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Forest Investigative Site 016
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31969269
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs