Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

May 17, 2019 updated by: Forest Laboratories

A Long-term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

403

Phase

  • Phase 3

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

  • Hungary
      • Budapest, Hungary, 1083
        • Forest Investigative Site 301
      • Budapest, Hungary, 1135
        • Forest Investigative Site 302
      • Nyiregyhaza, Hungary, 4400
        • Forest Investigative Site 306
      • Szombathely, Hungary, 9700
        • Forest Investigative Site 308
    • Bekes
      • Gyula, Bekes, Hungary, 5700
        • Forest Investigative Site 309
  • Poland
      • Gdansk, Poland, 80-952
        • Forest Investigative Site 407
      • Gorlice, Poland, 38-300
        • Forest Investigative Site 401
      • Swiecie, Poland, 86-100
        • Forest Investigative Site 408
    • Kodz
      • Tuszyn, Kodz, Poland, 95-080
        • Forest Investigative Site 402
    • Silesian
      • Katowice, Silesian, Poland, 40-340
        • Forest Investigative Site 404
  • Spain
      • Barcelona, Spain, 08036
        • Forest Investigative Site 505
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Forest Investigative Site 015
    • California
      • Carson, California, United States, 90746
        • Forest Investigative Site 010
      • Cerritos, California, United States, 90703
        • Forest Investigative Site 020
      • Escondido, California, United States, 92025
        • Forest Investigative Site 009
      • Garden Grove, California, United States, 92845
        • Forest Investigative Site 004
      • San Diego, California, United States, 92102
        • Forest Investigative Site 016
      • Santa Ana, California, United States, 92701
        • Forest Investigative Site 007
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Forest Investigative Site 023
    • Florida
      • Bradenton, Florida, United States, 34208
        • Forest Investigative Site 001
      • Fort Lauderdale, Florida, United States, 33308
        • Forest Investigative Site 006
      • Kissimmee, Florida, United States, 34741
        • Forest Investigative Site 013
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Forest Investigative Site 021
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Forest Investigative Site 024
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Forest Investigative Site 022
      • Saint Charles, Missouri, United States, 63301
        • Forest Investigative Site 003
      • Saint Louis, Missouri, United States, 63118
        • Forest Investigative Site 025
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Forest Investigative Site 012
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
        • Forest Investigative Site 002
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Forest Investigative Site 005
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Forest Investigative Site 011
    • Texas
      • Austin, Texas, United States, 78731
        • Forest Investigative Site 017
      • Austin, Texas, United States, 78754
        • Forest Investigative Site 014
      • DeSoto, Texas, United States, 75115
        • Forest Investigative Site 018
      • Houston, Texas, United States, 77008
        • Forest Investigative Site 019

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:

  • Patients who have provided informed consent prior to any study specific procedures.
  • Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
  • Patients who experienced a manic or mixed episode that required treatment within the past 12 months.
  • Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

Exclusion Criteria:

  • Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cariprazine 3-12 mg/day for 16 weeks
Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator.
Drug: Cariprazine
Cariprazine was supplied in capsules.
Other Names:
  • RGH-188

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the YMRS Total Score at Week 16
Time Frame: Baseline to Week 16
The Young Mania Rating Scale (YMRS) is an 11-item scale that assesses manic symptoms based on the patient's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11 items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of each item is rated on a 5-point (0-4) or a 9-point (0-8) scale. The total score of all 11 items can range from 0 to 60. A higher score indicates worse manic symptoms. A negative change score indicates improvement.
Baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the MADRS Total Score at Week 16
Time Frame: Baseline to Week 16
The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated scale that evaluates the patient's depressive symptomatology during the previous week. Patients are rated on 10 items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point (0-6) scale. The total score can range from 0 to 42. A higher score indicates greater depressive symptomatology. A negative change score indicates improvement.
Baseline to Week 16

Collaborators and Investigators

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

Sponsor

Forest Laboratories

Collaborators

Gedeon Richter Ltd.

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)

February 28, 2010

Primary Completion (Actual)

February 29, 2012

Study Completion (Actual)

February 29, 2012

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

February 1, 2010

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGH-MD-36

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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