Clinical trial NCT01396447: Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
Official title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression, Bipolar
Keywords: Bipolar I disorder
Bipolar depression
Depression
Bipolar disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2011-07-18
Enrollment: 584
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 was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.


Eligibility criteria: Inclusion Criteria:

* Participants who have provided informed consent prior to any study specific procedures.
* Participants 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 (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
* Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
* Verified previous manic or mixed episode.
* Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
* Participants with a HAMD-17 item 1 score ≥ 2.
* Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion Criteria:

* Participants 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 6 months.
* Women who are pregnant or breast feeding
* Participants with Young Mania Rating Scale (YMRS) total score \> 10
* Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.

Primary outcomes:
measure: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 021
state: Alabama
city: Springdale
country: United States
facility: Forest Investigative Site 017
state: Arkansas
city: Beverly Hills
country: United States
facility: Forest Investigative Site 030
state: California
city: Cerritos
country: United States
facility: Forest Investigative Site 018
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site 028
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site 015
state: California
city: Temecula
country: United States
facility: Forest Investigative Site 011
state: California
city: Jacksonville
country: United States
facility: Forest Investigative Site 012
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 035
state: Florida
city: Winter Park
country: United States
facility: Forest Investigative Site 013
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 038
state: Georgia
city: Atlanta
country: United States
facility: Forest Investigative Site 005
state: Georgia
city: Chicago
country: United States
facility: Forest Investigative Site 029
state: Illinois
city: Indianapolis
country: United States
facility: Forest Investigative Site 024
state: Indiana
city: Prairie Village
country: United States
facility: Forest Investigative Site 031
state: Kansas
city: Lake Charles
country: United States
facility: Forest Investigative Site 041
state: Louisiana
city: Shreveport
country: United States
facility: Forest Investigative Site 040
state: Louisiana
city: Flowood
country: United States
facility: Forest Investigative Site 039
state: Mississippi
city: Creve Coeur
country: United States
facility: Forest Investigative Site 026
state: Missouri
city: Las Vegas
country: United States
facility: Forest Investigative Site 037
state: Nevada
city: Cherry Hill
country: United States
facility: Forest Investigative Site 023
state: New Jersey
city: Marlton
country: United States
facility: Forest Investigative Site 014
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site 006
state: New Mexico
city: Brooklyn
country: United States
facility: Forest Investigative Site 003
state: New York
city: New York
country: United States
facility: Forest Investigative Site 025
state: New York
city: Canton
country: United States
facility: Forest Investigative Site 036
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative Site 008
state: Ohio
city: Salem
country: United States
facility: Forest Investigative Site 042
state: Oregon
city: Allentown
country: United States
facility: Forest Investigative Site 009
state: Pennsylvania
city: Media
country: United States
facility: Forest Investigative Site 010
state: Pennsylvania
city: Lincoln
country: United States
facility: Forest Investigative Site 033
state: Rhode Island
city: Memphis
country: United States
facility: Forest Investigative Site 019
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site 007
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 016
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 027
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 020
state: Texas
city: Bellevue
country: United States
facility: Forest Investigative Site 043
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site 032
state: Washington
city: Kardzhali
country: Bulgaria
facility: Forest Investigative Site 311
city: Kazanlak
country: Bulgaria
facility: Forest Investigative Site 307
city: Lovech
country: Bulgaria
facility: Forest Investigative Site 310
city: Novi Iskar
country: Bulgaria
facility: Forest Investigative Site 313
city: Pazardzhik
country: Bulgaria
facility: Forest Investigative Site 309
city: Pleven
country: Bulgaria
facility: Forest Investigative Site 302
city: Plovdiv
country: Bulgaria
facility: Forest Investigative Site 301
city: Sofia
country: Bulgaria
facility: Forest Investigative Site 305
city: Sofia
country: Bulgaria
facility: Forest Investigative Site 306
city: Tsarev Brod
country: Bulgaria
facility: Forest Investigative Site 308
city: Tserova Koria
country: Bulgaria
facility: Forest Investigative Site 312
city: Kelowna
country: Canada
facility: Forest Investigative Site 102
state: British Columbia
city: Penticton
country: Canada
facility: Forest Investigative Site 103
state: British Columbia
city: Chatham
country: Canada
facility: Forest Investigative Site 101
state: Ontario
city: Barranquilla
country: Colombia
facility: Forest Investigative Site 804
city: Barranquilla
country: Colombia
facility: Forest Investigative Site 806
city: Bogota
country: Colombia
facility: Forest Investigative Site 803
city: Bogotá
country: Colombia
facility: Forest Investigative Site 805
city: Bogotá
country: Colombia
facility: Forest Investigative Site 808
city: Pereira
country: Colombia
facility: Forest Investigative Site 807
city: Arkhangelsk
country: Russian Federation
facility: Forest Investigative Site 601
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 605
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 607
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 611
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 619
city: Nizhniy Novgorod
country: Russian Federation
facility: Forest Investigative Site 603
city: Saint-Petersburg
country: Russian Federation
facility: Forest Investigative Site 612
city: Samara
country: Russian Federation
facility: Forest Investigative Site 617
city: Saratov
country: Russian Federation
facility: Forest Investigative Site 616
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 604
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 606
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 602
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 613
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 608
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 615
city: Tomsk
country: Russian Federation
facility: Forest Investigative Site 609
city: Tver
country: Russian Federation
facility: Forest Investigative Site 618
city: Voronezh
country: Russian Federation
facility: Forest Investigative Site 610
city: Kerch
country: Ukraine
facility: Forest Investigative Site 707
state: AR Crimea
city: Kherson
country: Ukraine
facility: Forest Investigative Site 709
state: Vil. Stepanivka
city: Donetsk
country: Ukraine
facility: Forest Investigative Site 714
city: Ivano-Frankivsk
country: Ukraine
facility: Forest Investigative Site 712
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 703
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 704
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 702
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 708
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 701
city: Odesa
country: Ukraine
facility: Forest Investigative Site 710
city: Simferopol
country: Ukraine
facility: Forest Investigative Site 706
city: Vinnytsia
country: Ukraine
facility: Forest Investigative Site 705
Study officials:
affiliation: Allergan
name: Willie Earley, MD
role: STUDY_DIRECTOR
References:
citation: Vieta E, Calabrese JR, Whelan J, Tohen M, Earley WR. The efficacy of cariprazine on function in patients with bipolar depression: a post hoc analysis of a randomized controlled trial. Curr Med Res Opin. 2021 Sep;37(9):1635-1643. doi: 10.1080/03007995.2021.1932446. Epub 2021 Jun 7.
citation: Citrome L, Yatham LN, Patel MD, Barabassy A, Hankinson A, Earley WR. Cariprazine and akathisia, restlessness, and extrapyramidal symptoms in patients with bipolar depression. J Affect Disord. 2021 Jun 1;288:191-198. doi: 10.1016/j.jad.2021.03.076. Epub 2021 Mar 31.
citation: Thase ME, Harrington A, Calabrese J, Montgomery S, Niu X, Patel MD. Evaluation of MADRS severity thresholds in patients with bipolar depression. J Affect Disord. 2021 May 1;286:58-63. doi: 10.1016/j.jad.2021.02.043. Epub 2021 Feb 20.
citation: Yatham LN, Vieta E, McIntyre RS, Jain R, Patel M, Earley W. Broad Efficacy of Cariprazine on Depressive Symptoms in Bipolar Disorder and the Clinical Implications. Prim Care Companion CNS Disord. 2020 Sep 17;22(5):20m02611. doi: 10.4088/PCC.20m02611.
citation: Earley WR, Burgess M, Rekeda L, Hankinson A, McIntyre RS, Suppes T, Calabrese JR, Yatham LN. A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression. J Affect Disord. 2020 Feb 15;263:386-395. doi: 10.1016/j.jad.2019.11.098. Epub 2019 Nov 22.
citation: Durgam S, Earley W, Lipschitz A, Guo H, Laszlovszky I, Nemeth G, Vieta E, Calabrese JR, Yatham LN. An 8-Week Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar I Depression. Am J Psychiatry. 2016 Mar 1;173(3):271-81. doi: 10.1176/appi.ajp.2015.15020164. Epub 2015 Nov 6.