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

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

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Locations

United States, Arkansas
Forest Investigative Site 015
Springdale, Arkansas, United States, 72764
United States, California
Forest Investigative Site 010
Carson, California, United States, 90746
Forest Investigative Site 020
Cerritos, California, United States, 90703
Forest Investigative Site 009
Escondido, California, United States, 92025
Forest Investigative Site 004
Garden Grove, California, United States, 92845
Forest Investigative Site 016
San Diego, California, United States, 92102
Forest Investigative Site 007
Santa Ana, California, United States, 92701
United States, District of Columbia
Forest Investigative Site 023
Washington, District of Columbia, United States, 20016
United States, Florida
Forest Investigative Site 001
Bradenton, Florida, United States, 34208
Forest Investigative Site 006
Ft. Lauderdale, Florida, United States, 33308
Forest Investigative Site 013
Kissimmee, Florida, United States, 34741
United States, Maryland
Forest Investigative Site 021
Rockville, Maryland, United States, 20850
United States, Mississippi
Forest Investigative Site 024
Flowood, Mississippi, United States, 39232
United States, Missouri
Forest Investigative Site 022
Creve Coeur, Missouri, United States, 63141
Forest Investigative Site 003
St. Charles, Missouri, United States, 63301
Forest Investigative Site 025
St. Louis, Missouri, United States, 63118
United States, Nevada
Forest Investigative Site 012
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Forest Investigative Site 002
Willingboro, New Jersey, United States, 08046
United States, Ohio
Forest Investigative Site 005
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Forest Investigative Site 011
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
Forest Investigative Site 014
Austin, Texas, United States, 78754
Forest Investigative Site 017
Austin, Texas, United States, 78731
Forest Investigative Site 018
DeSoto, Texas, United States, 75115
Forest Investigative Site 019
Houston, Texas, United States, 77008
Hungary
Forest Investigative Site 309
Gyula, Bekes, Hungary, 5700
Forest Investigative Site 301
Budapest, Hungary, 1083
Forest Investigative Site 302
Budapest, Hungary, 1135
Forest Investigative Site 306
Nyiregyhaza, Hungary, 4400
Forest Investigative Site 308
Szombathely, Hungary, 9700
Poland
Forest Investigative Site 402
Tuszyn, Kodz, Poland, 95-080
Forest Investigative Site 404
Katowice, Silesian, Poland, 40-340
Forest Investigative Site 407
Gdansk, Poland, 80-952
Forest Investigative Site 401
Gorlice, Poland, 38-300
Forest Investigative Site 408
Swiecie, Poland, 86-100
Spain
Forest Investigative Site 505
Barcelona, Spain, 08036

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 May 19, 2013