Safety and Efficacy of Cariprazine for Bipolar I Disorder

March 1, 2017 updated by: Forest Laboratories

A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

497

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

  • Croatia
      • Rijeka, Croatia, 51 000
        • Forest Investigative Site 607
      • Zagreb, Croatia, 10 000
        • Forest Investigative Site 602
      • Zagreb, Croatia, 10 000
        • Forest Investigative Site 605
      • Zagreb, Croatia, 10 090
        • Forest Investigative Site 606
  • Romania
      • Arad, Romania, 310022
        • Forest Investigative Site 209
      • Bucharest, Romania, 041915
        • Forest Investigative Site 203
      • Bucuresti, Romania, 041915
        • Forest Investigative Site 205
      • Bucuresti, Romania, 041915
        • Forest Investigative Site 206
      • Bucuresti, Romania, 041915
        • Forest Investigative Site 208
      • Constanta, Romania, 900002
        • Forest Investigative Site 202
      • Craiova, Romania, 200260
        • Forest Investigative Site 201
    • Dambovita
      • Targoviste, Dambovita, Romania, 130086
        • Forest Investigative Site 204
    • Dolj
      • Craiova, Dolj, Romania, 200745
        • Forest Investigative Site 210
    • Timis
      • Timisoara, Timis, Romania, 300182
        • Forest Investigative Site 211
    • Vrancea
      • Focsani, Vrancea, Romania, 620165
        • Forest Investigative Site 212
  • Russian Federation
      • Lipetsk, Russian Federation, 398007
        • Forest Investigative Site 501
      • Moscow, Russian Federation, 115522
        • Forest Investigative Site 503
      • Moscow, Russian Federation, 115522
        • Forest Investigative Site 507
      • Moscow, Russian Federation, 115522
        • Forest Investigative Site 510
      • Saint Petersburg, Russian Federation, 190005
        • Forest Investigative Site 506
      • Saint Petersburg, Russian Federation, 190121
        • Forest Investigative Site 508
      • Samara, Russian Federation, 443016
        • Forest Investigative Site 509
      • Saratov, Russian Federation, 410028
        • Forest Investigative Site 504
      • Smolensk, Russian Federation, 214019
        • Forest Investigative Site 502
  • Serbia
      • Belgrade, Serbia, 11000
        • Forest Investigative Site 403
      • Belgrade, Serbia, 11000
        • Forest Investigative Site 404
      • Belgrade, Serbia, 11000
        • Forest Investigative Site 405
      • Kragujevac, Serbia, 34000
        • Forest Investigative Site 402
      • Senta, Serbia, 24400
        • Forest Investigative Site 401
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49027
        • Forest Investigative Site 308
      • Dnipropetrovsk, Ukraine, 49115
        • Forest Investigative Site 315
      • Donetsk, Ukraine, 83008
        • Forest Investigative Site 301
      • Kharkiv, Ukraine, 61068
        • Forest Investigative Site 307
      • Kharkiv, Ukraine, 61068
        • Forest Investigative Site 310
      • Kyiv, Ukraine, 01030
        • Forest Investigative Site 304
      • Kyiv, Ukraine, 02660
        • Forest Investigative Site 305
      • Kyiv, Ukraine, 04080
        • Forest Investigative Site 303
      • Kyiv, Ukraine, 04080
        • Forest Investigative Site 309
      • Kyiv, Ukraine, 08631
        • Forest Investigative Site 312
      • Lugansk, Ukraine, 91045
        • Forest Investigative Site 306
      • Lviv, Ukraine, 79021
        • Forest Investigative Site 311
      • Odessa, Ukraine, 65006
        • Forest Investigative Site 302
      • Poltava, Ukraine, 36006
        • Forest Investigative Site 314
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Forest Investigative Site 018
    • California
      • Cerritos, California, United States, 90703
        • Forest Investigative Site 012
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 010
      • Oceanside, California, United States, 92056
        • Forest Investigative Site 005
      • San Diego, California, United States, 92102
        • Forest Investigative Site 023
      • San Diego, California, United States, 92103
        • Forest Investigative Site 017
      • Santa Ana, California, United States, 92701
        • Forest Investigative Site 024
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • Forest Investigative Site 016
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Forest Investigative Site 007
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Forest Investigative Site 002
      • Orlando, Florida, United States, 32821
        • Forest Investigative Site 003
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Forest Investigative Site 026
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Forest Investigative Site 013
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Forest Investigative Site 011
    • Indiana
      • Greenwood, Indiana, United States, 46143
        • Forest Investigative Site 021
    • Louisiana
      • Shreveport, Louisiana, United States, 71115
        • Forest Investigative Site 001
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Forest Investigative Site 006
    • Missouri
      • St. Louis, Missouri, United States, 63118
        • Forest Investigative Site 025
    • New York
      • Cedarhurst, New York, United States, 11516
        • Forest Investigative Site 008
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Forest Investigative Site 019
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site 015
    • Texas
      • Irving, Texas, United States, 75062
        • Forest Investigative Site 004
    • Washington
      • Bothell, Washington, United States, 98011
        • Forest Investigative Site 014

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) manic or mixed type with or without psychotic symptoms
  • Voluntarily hospitalized for current manic episode
  • Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

  • Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Drug: Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.
Experimental: Cariprazine (3-6 mg/day)
Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Experimental: Cariprazine (6-12 mg/day)
Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3
Time Frame: Baseline, Week 3
The YMRS is an 11-item scale that assesses manic symptoms based on the participant'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 the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
Baseline, Week 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3
Time Frame: Baseline, Week 3
The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
Baseline, Week 3

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

February 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGH-MD-33

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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