Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
NCT ID: NCT01396447
Last Updated: 2018-05-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
584 participants
INTERVENTIONAL
2011-07-26
2014-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received placebo orally once a day for 8 weeks.
Placebo
Placebo was supplied in capsules.
Cariprazine 0.75 mg
Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
Cariprazine
Cariprazine was supplied in capsules.
Cariprazine 1.5 mg
Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
Cariprazine
Cariprazine was supplied in capsules.
Cariprazine 3.0 mg
Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
Cariprazine
Cariprazine was supplied in capsules.
Interventions
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Placebo
Placebo was supplied in capsules.
Cariprazine
Cariprazine was supplied in capsules.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Gedeon Richter Ltd.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Willie Earley, MD
Role: STUDY_DIRECTOR
Allergan
Locations
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Forest Investigative Site 021
Birmingham, Alabama, United States
Forest Investigative Site 017
Springdale, Arkansas, United States
Forest Investigative Site 030
Beverly Hills, California, United States
Forest Investigative Site 018
Cerritos, California, United States
Forest Investigative Site 028
Costa Mesa, California, United States
Forest Investigative Site 015
Oceanside, California, United States
Forest Investigative Site 011
Temecula, California, United States
Forest Investigative Site 012
Jacksonville, Florida, United States
Forest Investigative Site 035
Orlando, Florida, United States
Forest Investigative Site 013
Winter Park, Florida, United States
Forest Investigative Site 038
Atlanta, Georgia, United States
Forest Investigative Site 005
Atlanta, Georgia, United States
Forest Investigative Site 029
Chicago, Illinois, United States
Forest Investigative Site 024
Indianapolis, Indiana, United States
Forest Investigative Site 031
Prairie Village, Kansas, United States
Forest Investigative Site 041
Lake Charles, Louisiana, United States
Forest Investigative Site 040
Shreveport, Louisiana, United States
Forest Investigative Site 039
Flowood, Mississippi, United States
Forest Investigative Site 026
Creve Coeur, Missouri, United States
Forest Investigative Site 037
Las Vegas, Nevada, United States
Forest Investigative Site 023
Cherry Hill, New Jersey, United States
Forest Investigative Site 014
Marlton, New Jersey, United States
Forest Investigative Site 006
Albuquerque, New Mexico, United States
Forest Investigative Site 003
Brooklyn, New York, United States
Forest Investigative Site 025
New York, New York, United States
Forest Investigative Site 036
Canton, Ohio, United States
Forest Investigative Site 008
Dayton, Ohio, United States
Forest Investigative Site 042
Salem, Oregon, United States
Forest Investigative Site 009
Allentown, Pennsylvania, United States
Forest Investigative Site 010
Media, Pennsylvania, United States
Forest Investigative Site 033
Lincoln, Rhode Island, United States
Forest Investigative Site 019
Memphis, Tennessee, United States
Forest Investigative Site 007
Dallas, Texas, United States
Forest Investigative Site 016
Houston, Texas, United States
Forest Investigative Site 027
Houston, Texas, United States
Forest Investigative Site 020
San Antonio, Texas, United States
Forest Investigative Site 043
Bellevue, Washington, United States
Forest Investigative Site 032
Seattle, Washington, United States
Forest Investigative Site 311
Kardzhali, , Bulgaria
Forest Investigative Site 307
Kazanlak, , Bulgaria
Forest Investigative Site 310
Lovech, , Bulgaria
Forest Investigative Site 313
Novi Iskar, , Bulgaria
Forest Investigative Site 309
Pazardzhik, , Bulgaria
Forest Investigative Site 302
Pleven, , Bulgaria
Forest Investigative Site 301
Plovdiv, , Bulgaria
Forest Investigative Site 305
Sofia, , Bulgaria
Forest Investigative Site 306
Sofia, , Bulgaria
Forest Investigative Site 308
Tsarev Brod, , Bulgaria
Forest Investigative Site 312
Tserova Koria, , Bulgaria
Forest Investigative Site 102
Kelowna, British Columbia, Canada
Forest Investigative Site 103
Penticton, British Columbia, Canada
Forest Investigative Site 101
Chatham, Ontario, Canada
Forest Investigative Site 804
Barranquilla, , Colombia
Forest Investigative Site 806
Barranquilla, , Colombia
Forest Investigative Site 803
Bogotá, , Colombia
Forest Investigative Site 805
Bogotá, , Colombia
Forest Investigative Site 808
Bogotá, , Colombia
Forest Investigative Site 807
Pereira, , Colombia
Forest Investigative Site 601
Arkhangelsk, , Russia
Forest Investigative Site 605
Moscow, , Russia
Forest Investigative Site 607
Moscow, , Russia
Forest Investigative Site 611
Moscow, , Russia
Forest Investigative Site 619
Moscow, , Russia
Forest Investigative Site 603
Nizhny Novgorod, , Russia
Forest Investigative Site 604
Saint Petersburg, , Russia
Forest Investigative Site 606
Saint Petersburg, , Russia
Forest Investigative Site 602
Saint Petersburg, , Russia
Forest Investigative Site 613
Saint Petersburg, , Russia
Forest Investigative Site 608
Saint Petersburg, , Russia
Forest Investigative Site 615
Saint Petersburg, , Russia
Forest Investigative Site 612
Saint Petersburg, , Russia
Forest Investigative Site 617
Samara, , Russia
Forest Investigative Site 616
Saratov, , Russia
Forest Investigative Site 609
Tomsk, , Russia
Forest Investigative Site 618
Tver', , Russia
Forest Investigative Site 610
Voronezh, , Russia
Forest Investigative Site 707
Kerch, AR Crimea, Ukraine
Forest Investigative Site 709
Kherson, Vil. Stepanivka, Ukraine
Forest Investigative Site 714
Donetsk, , Ukraine
Forest Investigative Site 712
Ivano-Frankivsk, , Ukraine
Forest Investigative Site 703
Kharkiv, , Ukraine
Forest Investigative Site 704
Kharkiv, , Ukraine
Forest Investigative Site 702
Kharkiv, , Ukraine
Forest Investigative Site 708
Kyiv, , Ukraine
Forest Investigative Site 701
Kyiv, , Ukraine
Forest Investigative Site 710
Odesa, , Ukraine
Forest Investigative Site 706
Simferopol, , Ukraine
Forest Investigative Site 705
Vinnytsia, , Ukraine
Countries
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References
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McIntyre RS, Llorca PM, Aronin LC, Yu J, Nguyen HB. Effect of Cariprazine on Anhedonia in Patients with Bipolar I Depression: Post Hoc Analysis of Three Randomized Placebo-Controlled Clinical Trials. Adv Ther. 2025 Jan;42(1):246-260. doi: 10.1007/s12325-024-03009-2. Epub 2024 Nov 9.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2011-002334-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RGH-MD-56
Identifier Type: -
Identifier Source: org_study_id
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