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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01059539
Recruitment Status : Completed
First Posted : February 1, 2010
Last Update Posted : December 10, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Drug: cariprazine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cariprazine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Clinical laboratory [ Time Frame: 16 weeks ]
  2. Electrocardiogram [ Time Frame: 16 weeks ]
  3. Adverse events [ Time Frame: 16 weeks ]
  4. Physical Examinations [ Time Frame: 16 weeks ]
  5. Extrapyramidal symptomatology [ Time Frame: 16 weeks ]
  6. Ophthalmology [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059539

  Show 35 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Study Director: Elizabeth Diaz, MD Forest Laboratories
More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01059539     History of Changes
Other Study ID Numbers: RGH-MD-36
First Posted: February 1, 2010    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012

Keywords provided by Forest Laboratories:
acute mania
bipolar I disorder

Additional relevant MeSH terms:
Pathologic Processes