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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014