Clinical trial NCT01104779: Safety and Efficacy of Cariprazine in Schizophrenia
Official title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of 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: 446
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided informed consent 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)
* Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
* Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
* Patients in their first episode of psychosis
* Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
* Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
* Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
* Substance abuse or dependence within the prior 3 months

Primary outcomes:
measure: Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Forest Investigative Site 48
state: California
city: Long Beach
country: United States
facility: Forest Investigative Site 50
state: California
city: Paramount
country: United States
facility: Forest Investigative Site 42
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 054
state: California
city: Kissimmee
country: United States
facility: Forest Investigative Site 41
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 055
state: Georgia
city: Rockville
country: United States
facility: Forest Investigative Site 44
state: Maryland
city: Saint Louis
country: United States
facility: Forest Investigative Site 45
state: Missouri
city: Las Vegas
country: United States
facility: Forest Investigative Site 52
state: Nevada
city: Cedarhurst
country: United States
facility: Forest Investigative Site 40
state: New York
city: Cincinnati
country: United States
facility: Forest Investigative Site 46
state: Ohio
city: Philadelphia
country: United States
facility: Forest Investigative Site 47
state: Pennsylvania
city: Memphis
country: United States
facility: Forest Investigative 49
state: Tennessee
city: Houston
country: United States
facility: Forest Investigative Site 51
state: Texas
city: Irving
country: United States
facility: Forest Investigative Site 43
state: Texas
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: Vijayawada
country: India
facility: Forest Investigative Site 505
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: Forest Investigative Site 514
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Forest Investigative Site 503
state: Gujarat
city: Ahmedabad
country: India
facility: Forest Investigative Site 519
state: Gujarat
city: Ahmedabad
country: India
facility: Forest Investigative Site 501
state: Gujarat
city: Ahmedabad
country: India
facility: Forest Investigative Site 508
state: Gujarat
city: Bangalore
country: India
facility: Forest Investigative Site 504
state: Karna
city: Mangalore
country: India
facility: Forest Investigative Site 517
state: Karna
city: Mangalore
country: India
facility: Forest Investigative Site 515
state: Karna
city: Mysore
country: India
facility: Forest Investigative Site 516
state: Karna
city: Aurangabad
country: India
facility: Forest Investigative Site 500
state: Mahara
city: Mumbai
country: India
facility: Forest Investigative Site 510
state: Mahara
city: Nashik
country: India
facility: Forest Investigative Site 513
state: Mahara
city: Pune
country: India
facility: Forest Investigative Site 511
state: Mahara
city: Pune
country: India
facility: Forest Investigative Site 502
state: Mahara
city: Rajkot
country: India
facility: Forest Investigative Site 509
state: Rajastan
city: Kanpur
country: India
facility: Forest Investigative Site 507
state: Uttar Pradesh
city: Lucknow
country: India
facility: Forest Investigative Site 518
state: Uttar Pradesh
city: Varanasi
country: India
facility: Forest Investigative Site 506
state: Uttar Pradesh
city: Johannesburg
country: South Africa
facility: Forest Investigative Site 704
state: Gauteng
city: Cape Town
country: South Africa
facility: Forest Investigative Site 703
state: W Cape
city: Cape Town
country: South Africa
facility: Forest Investigative Site 706
state: W Cape
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: Marder S, Fleischhacker WW, Earley W, Lu K, Zhong Y, Nemeth G, Laszlovszky I, Szalai E, Durgam S. Efficacy of cariprazine across symptom domains in patients with acute exacerbation of schizophrenia: Pooled analyses from 3 phase II/III studies. Eur Neuropsychopharmacol. 2019 Jan;29(1):127-136. doi: 10.1016/j.euroneuro.2018.10.008. Epub 2018 Nov 20.
citation: Earley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187.
citation: Cutler AJ, Durgam S, Wang Y, Migliore R, Lu K, Laszlovszky I, Nemeth G. Evaluation of the long-term safety and tolerability of cariprazine in patients with schizophrenia: results from a 1-year open-label study. CNS Spectr. 2018 Feb;23(1):39-50. doi: 10.1017/S1092852917000220. Epub 2017 May 8.
citation: Citrome L, Durgam S, Lu K, Ferguson P, Laszlovszky I. The effect of cariprazine on hostility associated with schizophrenia: post hoc analyses from 3 randomized controlled trials. J Clin Psychiatry. 2016 Jan;77(1):109-15. doi: 10.4088/JCP.15m10192.