Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
446 participants
INTERVENTIONAL
2010-04-27
2011-12-15
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 once daily fixed-flexible low dose
Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Cariprazine (6-9 mg/day)
Cariprazine once daily fixed-flexible high dose
Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Placebo
Placebo
Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Interventions
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Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six 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 six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
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)
* 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 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
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 48
Costa Mesa, California, United States
Forest Investigative Site 50
Long Beach, California, United States
Forest Investigative Site 42
Paramount, California, United States
Forest Investigative Site 054
San Diego, California, United States
Forest Investigative Site 41
Kissimmee, Florida, United States
Forest Investigative Site 055
Atlanta, Georgia, United States
Forest Investigative Site 44
Rockville, Maryland, United States
Forest Investigative Site 45
St Louis, Missouri, United States
Forest Investigative Site 52
Las Vegas, Nevada, United States
Forest Investigative Site 40
Cedarhurst, New York, United States
Forest Investigative Site 46
Cincinnati, Ohio, United States
Forest Investigative Site 47
Philadelphia, Pennsylvania, United States
Forest Investigative 49
Memphis, Tennessee, United States
Forest Investigative Site 51
Houston, Texas, United States
Forest Investigative Site 43
Irving, Texas, 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 505
Vijayawada, Andhra Pradesh, India
Forest Investigative Site 514
Visakhapatnam, Andhra Pradesh, India
Forest Investigative Site 503
Ahmedabad, Gujarat, India
Forest Investigative Site 519
Ahmedabad, Gujarat, India
Forest Investigative Site 501
Ahmedabad, Gujarat, India
Forest Investigative Site 508
Ahmedabad, Gujarat, India
Forest Investigative Site 504
Bangalore, Karna, India
Forest Investigative Site 517
Mangalore, Karna, India
Forest Investigative Site 515
Mangalore, Karna, India
Forest Investigative Site 516
Mysore, Karna, India
Forest Investigative Site 500
Aurangabad, Mahara, India
Forest Investigative Site 510
Mumbai, Mahara, India
Forest Investigative Site 513
Nashik, Mahara, India
Forest Investigative Site 511
Pune, Mahara, India
Forest Investigative Site 502
Pune, Mahara, India
Forest Investigative Site 509
Rajkot, Rajasthan, India
Forest Investigative Site 507
Kanpur, Uttar Pradesh, India
Forest Investigative Site 518
Lucknow, Uttar Pradesh, India
Forest Investigative Site 506
Varanasi, Uttar Pradesh, India
Forest Investigative Site 704
Johannesburg, Gauteng, South Africa
Forest Investigative Site 703
Cape Town, W Cape, South Africa
Forest Investigative Site 706
Cape Town, W Cape, South Africa
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.
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.
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.
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.
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.
Other Identifiers
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RGH-MD-05
Identifier Type: -
Identifier Source: org_study_id
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