Clinical trial NCT01104792: Long-term Study of Cariprazine in Patients With Schizophrenia
Official title: Evaluation of the Long-term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Acute schizophrenia
Psychotropic drugs
Antipsychotic agents
Mental disorders
Dopamine agents
Central nervous system agents
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2010-04-15
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patients and corresponding caregivers who have provided informed consents 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 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:

* Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.

Primary outcomes:
measure: Change From Baseline to Week 48 in the PANSS Total Score
timeFrame: Baseline to Week 48
Secondary outcomes:
measure: Change From Baseline to Week 48 in the CGI-S Score
timeFrame: Baseline to Week 48
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Forest Investigative Site 072
state: Arkansas
city: Little Rock
country: United States
facility: Forest Investigative Site 021
state: Arkansas
city: Little Rock
country: United States
facility: Forest Investigative Site 086
state: Arkansas
city: Springdale
country: United States
facility: Forest Investigative Site 014
state: Arkansas
city: Carson
country: United States
facility: Forest Investigative Site 080
state: California
city: Cerritos
country: United States
facility: Forest Investigative Site 079
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site 048
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site 070
state: California
city: Garden Grove
country: United States
facility: Forest Investigative Site 022
state: California
city: Garden Grove
country: United States
facility: Forest Investigative Site 083
state: California
city: Long Beach
country: United States
facility: Forest Investigative Site 050
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site 006
state: California
city: Riverside
country: United States
facility: Forest Investigative Site 003
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 016
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 073
state: California
city: New Britain
country: United States
facility: Forest Investigative Site 071
state: Connecticut
city: Bradenton
country: United States
facility: Forest Investigative Site 002
state: Florida
city: Kissimmee
country: United States
facility: Forest Investigative Site 041
state: Florida
city: North Miami
country: United States
facility: Forest Investigative Site 082
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 055
state: Georgia
city: Atlanta
country: United States
facility: Forest Investigative Site 087
state: Georgia
city: Honolulu
country: United States
facility: Forest Investigative Site 012
state: Hawaii
city: Chicago
country: United States
facility: Forest Investigative Site 018
state: Illinois
city: Hoffman Estates
country: United States
facility: Forest Investigative Site 008
state: Illinois
city: Rockville
country: United States
facility: Forest Investigative Site 044
state: Maryland
city: Flowood
country: United States
facility: Forest Investigative Site 007
state: Mississippi
city: Creve Coeur
country: United States
facility: Forest Investigative Site 017
state: Missouri
city: Saint Charles
country: United States
facility: Forest Investigative Site 076
state: Missouri
city: Saint Louis
country: United States
facility: Forest Investigative Site 045
state: Missouri
city: Las Vegas
country: United States
facility: Forest Investigative Site 052
state: Nevada
city: Willingboro
country: United States
facility: Forest Investigative Site 004
state: New Jersey
city: Cedarhurst
country: United States
facility: Forest Investigative Site 040
state: New York
city: Willoughby
country: United States
facility: Forest Investigative Site 019
state: Ohio
city: Philadelphia
country: United States
facility: Forest Investigative Site 077
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 047
state: Pennsylvania
city: Austin
country: United States
facility: Forest Investigative Site 074
state: Texas
city: DeSoto
country: United States
facility: Forest Investigative Site 084
state: Texas
city: Irving
country: United States
facility: Forest Investigative Site 043
state: Texas
city: Bellevue
country: United States
facility: Forest Investigative Site 078
state: Washington
city: Bello
country: Colombia
facility: Forest Investigative Site 601
state: Antioquia
city: Pereira
country: Colombia
facility: Forest Investigative Site 604
state: Risaralda
city: Bogota
country: Colombia
facility: Forest Investigative Site 602
city: Bogota
country: Colombia
facility: Forest Investigative Site 605
city: Ahmedabad
country: India
facility: Forest Investigative Site 503
city: Ahmedabad
country: India
facility: Forest Investigative Site 519
city: Ahmedabad
country: India
facility: Forest Investigative Site 501
city: Aurangabad
country: India
facility: Forest Investigative Site 500
city: Kanpur
country: India
facility: Forest Investigative Site 507
city: Lucknow
country: India
facility: Forest Investigative Site 518
city: Mangalore
country: India
facility: Forest Investigative Site 517
city: Mangalore
country: India
facility: Forest Investigative Site 515
city: Mumbai
country: India
facility: Forest Investigative Site 510
city: Nashik
country: India
facility: Forest Investigative Site 513
city: Rajkot
country: India
facility: Forest Investigative Site 509
city: Varanasi
country: India
facility: Forest Investigative Site 506
city: Vijaywada
country: India
facility: Forest Investigative Site 505
city: Bucuresti
country: Romania
facility: Forest Investigative Site 306
city: Cluj-Napoca
country: Romania
facility: Forest Investigative Site 301
city: Craiova
country: Romania
facility: Forest Investigative Site 300
city: Craiova
country: Romania
facility: Forest Investigative Site 311
city: Targoviste
country: Romania
facility: Forest Investigative Site 303
city: Targu Mures
country: Romania
facility: Forest Investigative Site 304
city: Arkhangelsk
country: Russian Federation
facility: Forest Investigative Site 102
city: Chelyabinsk
country: Russian Federation
facility: Forest Investigative Site 103
city: Chita
country: Russian Federation
facility: Forest Investigative Site 104
city: Saratov
country: Russian Federation
facility: Forest Investigative Site 110
city: Saratov
country: Russian Federation
facility: Forest Investigative Site 108
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 112
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 105
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 106
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 113
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 107
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 109
city: Tomsk
country: Russian Federation
facility: Forest Investigative Site 100
city: Glevakha
country: Ukraine
facility: Forest Investigative Site 211
state: Kyiv Region
city: Kherson
country: Ukraine
facility: Forest Investigative Site 206
state: Stepanivka
city: Dnipropetrovsk
country: Ukraine
facility: Forest Investigative Site 208
city: Dnipropetrovsk
country: Ukraine
facility: Forest Investigative Site 205
city: Donetsk
country: Ukraine
facility: Forest Investigative Site 200
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 204
city: Kharkov
country: Ukraine
facility: Forest Investigative Site 203
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 201
city: Lviv
country: Ukraine
facility: Forest Investigative Site 202
city: Poltava
country: Ukraine
facility: Forest Investigative Site 209
city: Simferopol
country: Ukraine
facility: Forest Investigative Site 210
city: Vinnytsya
country: Ukraine
facility: Forest Investigative Site 207
Study officials:
affiliation: Forest Laboratories
name: Raffaele Migliore, MA
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.