Study Evaluating Cariprazine (RGH-188) in the Treatment of Patients With Acute Mania

March 1, 2017 updated by: Forest Laboratories

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in Patients With Acute Mania Associated With Bipolar I Disorder

This is a study designed to evaluate the efficacy, safety, and tolerability of RGH-188 monotherapy in the treatment of acute mania. This study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: RGH-188 or placebo

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 2

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

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63045
        • For information regarding investigative sites, contact Forest Professional Affairs

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:

  • Male or female inpatients 18 to 65 years of age
  • Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV) criteria for bipolar I disorder, acute manic or mixed episode

  • Having a total Young Mania Rating Scale (YMRS) score >= 20 and a score of at least 4 on two of the following YMRS items:

    • Irritability,
    • Speech,
    • Content, and
    • Disruptive/Aggressive Behavior

Exclusion Criteria:

  • Patients who exhibit abnormalities on physical examination, have abnormal vital-signs, electrocardiogram (ECG), or clinical laboratory values [such as thyroid-stimulating hormone (TSH)].
  • Patients with Montgomery-Åsberg Depression Rating Scale (MADRS) total score >= 18 at Visit 2.
  • Patients experiencing first manic episode.
  • Patients that have received electroconvulsive therapy (ECT) or a depot neuroleptic in the 3 months prior to Visit 1.

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
Experimental: Cariprazine
Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Drug: Cariprazine (RGH-188)
Cariprazine 3 mg - 12 mg oral administration, once per day.
Placebo Comparator: Placebo
Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Drug: Placebo
Dose-matched placebo oral administration, once per day.

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. Analyses are based on an Analysis of Covariance (ANCOVA) model for change from Baseline with treatment group and study center as factors and Baseline value as covariate.
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, 3 Weeks
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. Analyses are based on ANCOVA model for change from Baseline with treatment group and study center as factors and Baseline CGI-S score as covariate.
Baseline, 3 Weeks

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

June 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Actual)

April 14, 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-31

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.

Clinical Trials on Bipolar Disorder

Clinical Trials on Cariprazine (RGH-188)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe