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Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01059539
First received: January 27, 2010
Last updated: December 6, 2012
Last verified: December 2012
History of Changes

January 27, 2010
December 6, 2012
January 2010
March 2012   (final data collection date for primary outcome measure)
  • Clinical laboratory [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiogram [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Physical Examinations [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Extrapyramidal symptomatology [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Ophthalmology [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01059539 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
A Long-term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar I Disorder
Drug: cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.
Experimental: 1
Cariprazine flexible dose, oral administration once daily for 16 weeks
Intervention: Drug: cariprazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
403
March 2012
March 2012   (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)
  • Patients who experienced a manic or mixed episode that required treatment within the past 12 months
  • Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG)

Exclusion Criteria:

  • Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Hungary,   Poland,   Spain
 
NCT01059539
RGH-MD-36
No
Forest Laboratories
Forest Laboratories
Gedeon Richter Ltd.
Study Director: Elizabeth Diaz, MD Forest Laboratories
Forest Laboratories
December 2012

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