Long-term Study of Cariprazine in Patients With Schizophrenia
NCT ID: NCT01104792
Last Updated: 2019-07-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
752 participants
INTERVENTIONAL
2010-05-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cariprazine
Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
Cariprazine
Cariprazine was supplied in capsules.
Interventions
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Cariprazine
Cariprazine was supplied in capsules.
Other Intervention Names
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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 schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
* Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).
Exclusion Criteria
18 Years
60 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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Raffaele Migliore, MA
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Forest Investigative Site 072
Little Rock, Arkansas, United States
Forest Investigative Site 021
Little Rock, Arkansas, United States
Forest Investigative Site 086
Little Rock, Arkansas, United States
Forest Investigative Site 014
Springdale, Arkansas, United States
Forest Investigative Site 080
Carson, California, United States
Forest Investigative Site 079
Cerritos, California, United States
Forest Investigative Site 048
Costa Mesa, California, United States
Forest Investigative Site 070
Costa Mesa, California, United States
Forest Investigative Site 022
Garden Grove, California, United States
Forest Investigative Site 083
Garden Grove, California, United States
Forest Investigative Site 050
Long Beach, California, United States
Forest Investigative Site 006
Oceanside, California, United States
Forest Investigative Site 003
Riverside, California, United States
Forest Investigative Site 016
San Diego, California, United States
Forest Investigative Site 073
Santa Ana, California, United States
Forest Investigative Site 071
New Britain, Connecticut, United States
Forest Investigative Site 002
Bradenton, Florida, United States
Forest Investigative Site 041
Kissimmee, Florida, United States
Forest Investigative Site 082
North Miami, Florida, United States
Forest Investigative Site 055
Atlanta, Georgia, United States
Forest Investigative Site 087
Atlanta, Georgia, United States
Forest Investigative Site 012
Honolulu, Hawaii, United States
Forest Investigative Site 018
Chicago, Illinois, United States
Forest Investigative Site 008
Hoffman Estates, Illinois, United States
Forest Investigative Site 044
Rockville, Maryland, United States
Forest Investigative Site 007
Flowood, Mississippi, United States
Forest Investigative Site 017
Creve Coeur, Missouri, United States
Forest Investigative Site 076
Saint Charles, Missouri, United States
Forest Investigative Site 045
St Louis, Missouri, United States
Forest Investigative Site 052
Las Vegas, Nevada, United States
Forest Investigative Site 004
Willingboro, New Jersey, United States
Forest Investigative Site 040
Cedarhurst, New York, United States
Forest Investigative Site 019
Willoughby, Ohio, United States
Forest Investigative Site 077
Philadelphia, Pennsylvania, United States
Forest Investigative Site 047
Philadelphia, Pennsylvania, United States
Forest Investigative Site 074
Austin, Texas, United States
Forest Investigative Site 084
DeSoto, Texas, United States
Forest Investigative Site 043
Irving, Texas, United States
Forest Investigative Site 078
Bellevue, Washington, United States
Forest Investigative Site 601
Bello, Antioquia, Colombia
Forest Investigative Site 604
Pereira, Risaralda Department, Colombia
Forest Investigative Site 602
Bogotá, , Colombia
Forest Investigative Site 605
Bogotá, , Colombia
Forest Investigative Site 503
Ahmedabad, , India
Forest Investigative Site 519
Ahmedabad, , India
Forest Investigative Site 501
Ahmedabad, , India
Forest Investigative Site 500
Aurangabad, , India
Forest Investigative Site 507
Kanpur, , India
Forest Investigative Site 518
Lucknow, , India
Forest Investigative Site 517
Mangalore, , India
Forest Investigative Site 515
Mangalore, , India
Forest Investigative Site 510
Mumbai, , India
Forest Investigative Site 513
Nashik, , India
Forest Investigative Site 509
Rajkot, , India
Forest Investigative Site 506
Varanasi, , India
Forest Investigative Site 505
Vijaywada, , India
Forest Investigative Site 306
Bucharest, , Romania
Forest Investigative Site 301
Cluj-Napoca, , Romania
Forest Investigative Site 300
Craiova, , Romania
Forest Investigative Site 311
Craiova, , Romania
Forest Investigative Site 303
Târgovişte, , Romania
Forest Investigative Site 304
Târgu Mureş, , Romania
Forest Investigative Site 102
Arkhangelsk, , Russia
Forest Investigative Site 103
Chelyabinsk, , Russia
Forest Investigative Site 104
Chita, , Russia
Forest Investigative Site 112
Saint Petersburg, , Russia
Forest Investigative Site 105
Saint Petersburg, , Russia
Forest Investigative Site 106
Saint Petersburg, , Russia
Forest Investigative Site 113
Saint Petersburg, , Russia
Forest Investigative Site 107
Saint Petersburg, , Russia
Forest Investigative Site 109
Saint Petersburg, , Russia
Forest Investigative Site 110
Saratov, , Russia
Forest Investigative Site 108
Saratov, , Russia
Forest Investigative Site 100
Tomsk, , Russia
Forest Investigative Site 211
Hlevakha, Kyiv Oblast, Ukraine
Forest Investigative Site 206
Kherson, Stepanivka, Ukraine
Forest Investigative Site 208
Dnipropetrovsk, , Ukraine
Forest Investigative Site 205
Dnipropetrovsk, , Ukraine
Forest Investigative Site 200
Donetsk, , Ukraine
Forest Investigative Site 203
Kharkiv, , Ukraine
Forest Investigative Site 204
Kharkiv, , Ukraine
Forest Investigative Site 201
Kyiv, , Ukraine
Forest Investigative Site 202
Lviv, , Ukraine
Forest Investigative Site 209
Poltava, , Ukraine
Forest Investigative Site 210
Simferopol, , Ukraine
Forest Investigative Site 207
Vinnytsia, , Ukraine
Countries
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References
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Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6.
Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021.
Nasrallah HA, Earley W, Cutler AJ, Wang Y, Lu K, Laszlovszky I, Nemeth G, Durgam S. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis. BMC Psychiatry. 2017 Aug 24;17(1):305. doi: 10.1186/s12888-017-1459-z.
Other Identifiers
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RGH-MD-11
Identifier Type: -
Identifier Source: org_study_id
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