Safety and Efficacy of Cariprazine for Mania

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)

323

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

  • India
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, India, 520002
        • Forest Investigative Site 106
      • Vizag, Andhra Pradesh, India, 530017
        • Forest Investigative Site 112
    • Durgakund
      • Varanasi, Durgakund, India, 221005
        • Forest Investigator Site 108
    • Gujarat
      • Ahmedabad, Gujarat, India, 380013
        • Forest Investigative Site 103
      • Ahmedabad, Gujarat, India, 380015
        • Forest Investigative Site 120
    • Karnataka
      • Bangalore, Karnataka, India, 560010
        • Forest Investigative Site 105
      • Bangalore, Karnataka, India, 560027
        • Forest Investigative Site 107
      • Mangalore, Karnataka, India, 575001
        • Forest Investigative Site 118
      • Mangalore, Karnataka, India, 575018
        • Forest Investigative Site 113
      • Manipal, Karnataka, India, 576104
        • Forest Investigative Site 115
      • Mysore, Karnataka, India, 570004
        • Forest Investigative Site 114
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431005
        • Forest Investigative Site 101
      • Nasik, Maharashtra, India, 422101
        • Forest Investigative Site 110
      • Pune, Maharashtra, India, 411004
        • Forest Investigative Site 111
      • Pune, Maharashtra, India, 411030
        • Forest Investigative Site 104
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600003
        • Forest Investigative Site 121
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 200005
        • Forest Investigative Site 109
      • Lucknow, Uttar Pradesh, India, 226006
        • Forest Investigative Site 119
  • United States
    • California
      • Long Beach, California, United States, 90813
        • Forest Investigative Site 004
      • Riverside, California, United States, 92506
        • Forest Investigative Site 005
      • San Diego, California, United States, 92123
        • Forest Investigative Site 007
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Forest Investigative Site 009
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Forest Investigative Site 006
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Forest Investigative Site 001
    • Missouri
      • Creve Couer, Missouri, United States, 63141
        • Forest Investigative Site 003
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Forest Investigative Site 008
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Forest Investigative Site 010
    • Texas
      • Houston, Texas, United States, 77008
        • Forest Investigative Site 002

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cariprazine
Cariprazine 3 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.
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.

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 5-point scale (0-4) and 4-items on a 9-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 was a mixed model for repeated measurements (MMRM) observed cases (OC), 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 was based on a MMRM using the observed cases (OC) 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)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (ESTIMATE)

January 28, 2010

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 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-32

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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