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Safety and Efficacy of Cariprazine for Mania

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01058096
First received: January 27, 2010
Last updated: September 30, 2011
Last verified: September 2011
History of Changes

January 27, 2010
September 30, 2011
January 2010
July 2011   (final data collection date for primary outcome measure)
Young Mania Rating Scale (YMRS) [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01058096 on ClinicalTrials.gov Archive Site
Clinical Global Impression - Severity (CGI-S) [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Cariprazine for Mania
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Mania
  • Drug: Cariprazine
    Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine or placebo
  • Drug: Placebo
    Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine or placebo
  • Experimental: 1
    Cariprazine once daily flexible dose
    Intervention: Drug: Cariprazine
  • Placebo Comparator: 2
    Placebo once daily flexible dose
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
Not Provided
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT01058096
RGH-MD-32
No
Forest Laboratories
Forest Laboratories
Gedeon Richter Ltd.
Study Director: Elizabeth Diaz, MD Forest Laboratories
Forest Laboratories
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP