Safety and Efficacy of Cariprazine for Bipolar I Disorder
NCT ID: NCT01058668
Last Updated: 2017-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
497 participants
INTERVENTIONAL
2010-02-28
2011-12-31
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
TRIPLE
Study Groups
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Cariprazine (3-6 mg/day)
Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Cariprazine (6-12 mg/day)
Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Placebo
Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.
Interventions
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Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
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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Elizabeth Diaz, MD
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Forest Investigative Site 018
Little Rock, Arkansas, United States
Forest Investigative Site 012
Cerritos, California, United States
Forest Investigative Site 010
Costa Mesa, California, United States
Forest Investigative Site 005
Oceanside, California, United States
Forest Investigative Site 023
San Diego, California, United States
Forest Investigative Site 017
San Diego, California, United States
Forest Investigative Site 024
Santa Ana, California, United States
Forest Investigative Site 016
New Britain, Connecticut, United States
Forest Investigative Site 007
Washington D.C., District of Columbia, United States
Forest Investigative Site 002
Kissimmee, Florida, United States
Forest Investigative Site 003
Orlando, Florida, United States
Forest Investigative Site 026
Atlanta, Georgia, United States
Forest Investigative Site 013
Honolulu, Hawaii, United States
Forest Investigative Site 011
Hoffman Estates, Illinois, United States
Forest Investigative Site 021
Greenwood, Indiana, United States
Forest Investigative Site 001
Shreveport, Louisiana, United States
Forest Investigative Site 006
Rockville, Maryland, United States
Forest Investigative Site 025
St Louis, Missouri, United States
Forest Investigative Site 008
Cedarhurst, New York, United States
Forest Investigative Site 019
Philadelphia, Pennsylvania, United States
Forest Investigative Site 015
Memphis, Tennessee, United States
Forest Investigative Site 004
Irving, Texas, United States
Forest Investigative Site 014
Bothell, Washington, United States
Forest Investigative Site 607
Rijeka, , Croatia
Forest Investigative Site 602
Zagreb, , Croatia
Forest Investigative Site 605
Zagreb, , Croatia
Forest Investigative Site 606
Zagreb, , Croatia
Forest Investigative Site 210
Craiova, Dolj, Romania
Forest Investigative Site 204
Târgovişte, Dâmbovița County, Romania
Forest Investigative Site 211
Timișoara, Timiș County, Romania
Forest Investigative Site 212
Focşani, Vrancea, Romania
Forest Investigative Site 209
Arad, , Romania
Forest Investigative Site 203
Bucharest, , Romania
Forest Investigative Site 205
Bucharest, , Romania
Forest Investigative Site 206
Bucharest, , Romania
Forest Investigative Site 208
Bucharest, , Romania
Forest Investigative Site 202
Constanța, , Romania
Forest Investigative Site 201
Craiova, , Romania
Forest Investigative Site 501
Lipetsk, , Russia
Forest Investigative Site 503
Moscow, , Russia
Forest Investigative Site 507
Moscow, , Russia
Forest Investigative Site 510
Moscow, , Russia
Forest Investigative Site 506
Saint Petersburg, , Russia
Forest Investigative Site 508
Saint Petersburg, , Russia
Forest Investigative Site 509
Samara, , Russia
Forest Investigative Site 504
Saratov, , Russia
Forest Investigative Site 502
Smolensk, , Russia
Forest Investigative Site 403
Belgrade, , Serbia
Forest Investigative Site 404
Belgrade, , Serbia
Forest Investigative Site 405
Belgrade, , Serbia
Forest Investigative Site 402
Kragujevac, , Serbia
Forest Investigative Site 401
Senta, , Serbia
Forest Investigative Site 308
Dnipropetrovsk, , Ukraine
Forest Investigative Site 315
Dnipropetrovsk, , Ukraine
Forest Investigative Site 301
Donetsk, , Ukraine
Forest Investigative Site 307
Kharkiv, , Ukraine
Forest Investigative Site 310
Kharkiv, , Ukraine
Forest Investigative Site 304
Kyiv, , Ukraine
Forest Investigative Site 305
Kyiv, , Ukraine
Forest Investigative Site 303
Kyiv, , Ukraine
Forest Investigative Site 309
Kyiv, , Ukraine
Forest Investigative Site 312
Kyiv, , Ukraine
Forest Investigative Site 306
Luhansk, , Ukraine
Forest Investigative Site 311
Lviv, , Ukraine
Forest Investigative Site 302
Odesa, , Ukraine
Forest Investigative Site 314
Poltava, , Ukraine
Countries
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References
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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.
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.
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.
Other Identifiers
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RGH-MD-33
Identifier Type: -
Identifier Source: org_study_id
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