Safety and Efficacy of Cariprazine for Mania - Full Text View

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder Mania	Drug: Cariprazine Drug: Placebo	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Young Mania Rating Scale (YMRS) [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impression - Severity (CGI-S) [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]

Enrollment:	323
Study Start Date:	January 2010
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Cariprazine once daily flexible dose	Drug: Cariprazine Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine or placebo
Placebo Comparator: 2 Placebo once daily flexible dose	Drug: Placebo Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine or placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058096

Locations

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

Sponsors and Collaborators

Forest Laboratories

Gedeon Richter Ltd.

Investigators

Study Director:

Elizabeth Diaz, MD

Forest Laboratories

More Information

No publications provided

Responsible Party:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT01058096 History of Changes
Other Study ID Numbers:	RGH-MD-32
Study First Received:	January 27, 2010
Last Updated:	September 30, 2011
Health Authority:	United States: Food and Drug Administration India: Drugs Controller General of India

Keywords provided by Forest Laboratories:

Acute Mania
Bipolar I Disorder

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013