Clinical trial NCT01058668: Safety and Efficacy of Cariprazine for Bipolar I Disorder
Official title: A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mania
Bipolar I Disorder
Keywords: Acute Mania
Bipolar I Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2010-01-29
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated 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) manic or mixed type with or without psychotic symptoms
* Voluntarily hospitalized for current manic episode
* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months

Primary outcomes:
measure: Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3
timeFrame: Baseline, Week 3
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3
timeFrame: Baseline, Week 3
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Forest Investigative Site 018
state: Arkansas
city: Cerritos
country: United States
facility: Forest Investigative Site 012
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site 010
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site 005
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 023
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 017
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 024
state: California
city: New Britain
country: United States
facility: Forest Investigative Site 016
state: Connecticut
city: Washington
country: United States
facility: Forest Investigative Site 007
state: District of Columbia
city: Kissimmee
country: United States
facility: Forest Investigative Site 002
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 003
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 026
state: Georgia
city: Honolulu
country: United States
facility: Forest Investigative Site 013
state: Hawaii
city: Hoffman Estates
country: United States
facility: Forest Investigative Site 011
state: Illinois
city: Greenwood
country: United States
facility: Forest Investigative Site 021
state: Indiana
city: Shreveport
country: United States
facility: Forest Investigative Site 001
state: Louisiana
city: Rockville
country: United States
facility: Forest Investigative Site 006
state: Maryland
city: St. Louis
country: United States
facility: Forest Investigative Site 025
state: Missouri
city: Cedarhurst
country: United States
facility: Forest Investigative Site 008
state: New York
city: Philadelphia
country: United States
facility: Forest Investigative Site 019
state: Pennsylvania
city: Memphis
country: United States
facility: Forest Investigative Site 015
state: Tennessee
city: Irving
country: United States
facility: Forest Investigative Site 004
state: Texas
city: Bothell
country: United States
facility: Forest Investigative Site 014
state: Washington
city: Rijeka
country: Croatia
facility: Forest Investigative Site 607
city: Zagreb
country: Croatia
facility: Forest Investigative Site 602
city: Zagreb
country: Croatia
facility: Forest Investigative Site 605
city: Zagreb
country: Croatia
facility: Forest Investigative Site 606
city: Targoviste
country: Romania
facility: Forest Investigative Site 204
state: Dambovita
city: Craiova
country: Romania
facility: Forest Investigative Site 210
state: Dolj
city: Timisoara
country: Romania
facility: Forest Investigative Site 211
state: Timis
city: Focsani
country: Romania
facility: Forest Investigative Site 212
state: Vrancea
city: Arad
country: Romania
facility: Forest Investigative Site 209
city: Bucharest
country: Romania
facility: Forest Investigative Site 203
city: Bucuresti
country: Romania
facility: Forest Investigative Site 205
city: Bucuresti
country: Romania
facility: Forest Investigative Site 206
city: Bucuresti
country: Romania
facility: Forest Investigative Site 208
city: Constanta
country: Romania
facility: Forest Investigative Site 202
city: Craiova
country: Romania
facility: Forest Investigative Site 201
city: Lipetsk
country: Russian Federation
facility: Forest Investigative Site 501
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 503
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 507
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 510
city: Saint Petersburg
country: Russian Federation
facility: Forest Investigative Site 506
city: Saint Petersburg
country: Russian Federation
facility: Forest Investigative Site 508
city: Samara
country: Russian Federation
facility: Forest Investigative Site 509
city: Saratov
country: Russian Federation
facility: Forest Investigative Site 504
city: Smolensk
country: Russian Federation
facility: Forest Investigative Site 502
city: Belgrade
country: Serbia
facility: Forest Investigative Site 403
city: Belgrade
country: Serbia
facility: Forest Investigative Site 404
city: Belgrade
country: Serbia
facility: Forest Investigative Site 405
city: Kragujevac
country: Serbia
facility: Forest Investigative Site 402
city: Senta
country: Serbia
facility: Forest Investigative Site 401
city: Dnipropetrovsk
country: Ukraine
facility: Forest Investigative Site 308
city: Dnipropetrovsk
country: Ukraine
facility: Forest Investigative Site 315
city: Donetsk
country: Ukraine
facility: Forest Investigative Site 301
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 307
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 310
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 304
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 305
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 303
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 309
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 312
city: Lugansk
country: Ukraine
facility: Forest Investigative Site 306
city: Lviv
country: Ukraine
facility: Forest Investigative Site 311
city: Odessa
country: Ukraine
facility: Forest Investigative Site 302
city: Poltava
country: Ukraine
facility: Forest Investigative Site 314
Study officials:
affiliation: Forest Laboratories
name: Elizabeth Diaz, MD
role: STUDY_DIRECTOR
References:
citation: McIntyre RS, Masand PS, Earley W, Patel M. Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials. J Affect Disord. 2019 Oct 1;257:600-606. doi: 10.1016/j.jad.2019.07.020. Epub 2019 Jul 5.
citation: Earley W, Durgam S, Lu K, Ruth A, Nemeth G, Laszlovszky I, Yatham LN. Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder. J Affect Disord. 2018 Jan 15;226:239-244. doi: 10.1016/j.jad.2017.09.040. Epub 2017 Sep 25.
citation: Calabrese JR, Keck PE Jr, Starace A, Lu K, Ruth A, Laszlovszky I, Nemeth G, Durgam S. Efficacy and safety of low- and high-dose cariprazine in acute and mixed mania associated with bipolar I disorder: a double-blind, placebo-controlled study. J Clin Psychiatry. 2015 Mar;76(3):284-92. doi: 10.4088/JCP.14m09081.