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NCT01058096 Clinical Trial

Safety and Efficacy of Cariprazine for Mania

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01058096
Other study ID # RGH-MD-32
Secondary ID
Status Completed
Phase Phase 3
First received January 27, 2010
Last updated September 30, 2011
Start date January 2010

Study information
Verified date September 2011
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationIndia: Drugs Controller General of India
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 323
Est. completion date
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine or placebo
• Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine or placebo

Locations
Country Name City State
India Forest Investigative Site 103 Ahmedabad Gujarat
India Forest Investigative Site 120 Ahmedabad Gujarat
India Forest Investigative Site 101 Aurangabad Maharashtra
India Forest Investigative Site 105 Bangalore Karnataka
India Forest Investigative Site 107 Bangalore Karnataka
India Forest Investigative Site 121 Chennai Tamilnadu
India Forest Investigative Site 109 Kanpur Uttar Pradesh
India Forest Investigative Site 119 Lucknow Uttar Pradesh
India Forest Investigative Site 113 Mangalore Karnataka
India Forest Investigative Site 118 Mangalore Karnataka
India Forest Investigative Site 115 Manipal Karnataka
India Forest Investigative Site 114 Mysore Karnataka
India Forest Investigative Site 110 Nasik Maharashtra
India Forest Investigative Site 104 Pune Maharashtra
India Forest Investigative Site 111 Pune Maharashtra
India Forest Investigator Site 108 Varanasi Durgakund
India Forest Investigative Site 106 Vijayawada Andhra Pradesh
India Forest Investigative Site 112 Vizag Andhra Pradesh
United States Forest Investigative Site 009 Chicago Illinois
United States Forest Investigative Site 008 Cleveland Ohio
United States Forest Investigative Site 003 Creve Couer Missouri
United States Forest Investigative Site 001 Flowood Mississippi
United States Forest Investigative Site 002 Houston Texas
United States Forest Investigative Site 006 Lake Charles Louisiana
United States Forest Investigative Site 004 Long Beach California
United States Forest Investigative Site 010 Oklahoma City Oklahoma
United States Forest Investigative Site 005 Riverside California
United States Forest Investigative Site 007 San Diego California

Sponsors (2)
Lead Sponsor Collaborator
Forest Laboratories Gedeon Richter Ltd.

Countries where clinical trial is conducted

United States,  India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Young Mania Rating Scale (YMRS) 3 Weeks No
Secondary Clinical Global Impression - Severity (CGI-S) 3 Weeks No
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