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
  Purpose

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.


Condition Intervention Phase
Bipolar I Disorder
Drug: cariprazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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 ]

Enrollment: 403
Study Start Date: January 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cariprazine flexible dose, oral administration once daily for 16 weeks
Drug: cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.

  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)
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059539

  Show 35 Study Locations
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: NCT01059539     History of Changes
Other Study ID Numbers: RGH-MD-36
Study First Received: January 27, 2010
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board
European Union: European Medicines Agency

Keywords provided by Forest Laboratories:
mania
acute mania
bipolar I disorder

ClinicalTrials.gov processed this record on April 17, 2014