Clinical trial NCT01059539: Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
Official title: A Long-term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Keywords: Mania
Acute mania
Bipolar I disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2010-02-01
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in the YMRS Total Score at Week 16
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Change From Baseline in the MADRS Total Score at Week 16
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Forest Investigative Site 015
state: Arkansas
city: Carson
country: United States
facility: Forest Investigative Site 010
state: California
city: Cerritos
country: United States
facility: Forest Investigative Site 020
state: California
city: Escondido
country: United States
facility: Forest Investigative Site 009
state: California
city: Garden Grove
country: United States
facility: Forest Investigative Site 004
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 016
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 007
state: California
city: Washington
country: United States
facility: Forest Investigative Site 023
state: District of Columbia
city: Bradenton
country: United States
facility: Forest Investigative Site 001
state: Florida
city: Fort Lauderdale
country: United States
facility: Forest Investigative Site 006
state: Florida
city: Kissimmee
country: United States
facility: Forest Investigative Site 013
state: Florida
city: Rockville
country: United States
facility: Forest Investigative Site 021
state: Maryland
city: Flowood
country: United States
facility: Forest Investigative Site 024
state: Mississippi
city: Creve Coeur
country: United States
facility: Forest Investigative Site 022
state: Missouri
city: Saint Charles
country: United States
facility: Forest Investigative Site 003
state: Missouri
city: Saint Louis
country: United States
facility: Forest Investigative Site 025
state: Missouri
city: Las Vegas
country: United States
facility: Forest Investigative Site 012
state: Nevada
city: Willingboro
country: United States
facility: Forest Investigative Site 002
state: New Jersey
city: Cincinnati
country: United States
facility: Forest Investigative Site 005
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 011
state: Oklahoma
city: Austin
country: United States
facility: Forest Investigative Site 017
state: Texas
city: Austin
country: United States
facility: Forest Investigative Site 014
state: Texas
city: DeSoto
country: United States
facility: Forest Investigative Site 018
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 019
state: Texas
city: Gyula
country: Hungary
facility: Forest Investigative Site 309
state: Bekes
city: Budapest
country: Hungary
facility: Forest Investigative Site 301
city: Budapest
country: Hungary
facility: Forest Investigative Site 302
city: Nyiregyhaza
country: Hungary
facility: Forest Investigative Site 306
city: Szombathely
country: Hungary
facility: Forest Investigative Site 308
city: Tuszyn
country: Poland
facility: Forest Investigative Site 402
state: Kodz
city: Katowice
country: Poland
facility: Forest Investigative Site 404
state: Silesian
city: Gdansk
country: Poland
facility: Forest Investigative Site 407
city: Gorlice
country: Poland
facility: Forest Investigative Site 401
city: Swiecie
country: Poland
facility: Forest Investigative Site 408
city: Barcelona
country: Spain
facility: Forest Investigative Site 505
Study officials:
affiliation: Forest Laboratories
name: Elizabeth Diaz, MD
role: STUDY_DIRECTOR
References:
citation: Ketter TA, Sachs GS, Durgam S, Lu K, Starace A, Laszlovszky I, Nemeth G. The safety and tolerability of cariprazine in patients with manic or mixed episodes associated with bipolar I disorder: A 16-week open-label study. J Affect Disord. 2018 Jan 1;225:350-356. doi: 10.1016/j.jad.2017.08.040. Epub 2017 Aug 18.