Safety and Efficacy of Cariprazine in Patients With Schizophrenia
NCT ID: NCT01104766
Last Updated: 2018-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
617 participants
INTERVENTIONAL
2010-04-23
2011-12-20
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 3mg
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
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 6mg
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
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.
Aripiprazole 10mg
Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Aripiprazole
Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole 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.
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.
Aripiprazole
Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole 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)
* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
* Current psychotic episode (schizophrenia exacerbation) \< 2 weeks duration at Visit 1
* Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
* CGI-S score ≥ 4
Exclusion Criteria
* Bipolar I and II disorder
* Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
* DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
* Women who are pregnant or breast feeding
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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Woodland International Research Group, Inc.
Little Rock, Arkansas, United States
Woodland Research Northwest, LLC
Springdale, Arkansas, United States
Synergy Clinical Research of Escondido
Escondido, California, United States
Excell Research, Inc
Oceanside, California, United States
Clinical Innovations, Inc.
Riverside, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
Collaborative Neuroscience Network, Inc.
Torrance, California, United States
Colorado Clinical Trials, Inc.
Littleton, Colorado, United States
Comprehensive Clinical Development, Inc.
Washington D.C., District of Columbia, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
Hawaii Clinical Research Center
Honolulu, Hawaii, United States
Uptown Research Institute, LLC
Chicago, Illinois, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Precise Research Centers
Flowood, Mississippi, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, United States
CRI Worldwide, LLC
Willingboro, New Jersey, United States
Windsor-Laurelwood Center for Behavioral Medicine
Willoughby, Ohio, United States
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States
Claghorn-Lesem Research Clinic, Ltd.
Houston, Texas, United States
Pacific Institute of Medical Sciences
Bothell, Washington, United States
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Clinica X Psihiatrie
Bucharest, , Romania
Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica III Psihiatrie
Bucharest, , Romania
Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica VIII Psihiatrie
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Psihiatrie III
Cluj-Napoca, , Romania
Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie
Craiova, , Romania
Spitalul Clinic Militar de Urgenta, 'Dr. Stefan Odobleja' Clinical de Psihiatrie
Craiova, , Romania
Spitalul Judetean de Urgenta Piatra Neamt
Piatra Neamţ, , Romania
Spitalul Judetean de Urgenta Pitesti, Clinica de Psihiatrie
Piteşti, , Romania
Spitalul de Psihiatrie Dr. Gheorghe Preda" Sibiu
Sibiu, , Romania
Spitalul Judetean de Urgenta Targoviste, Sectia Psihiatrie
Târgovişte, , Romania
Spitalul Clinic Judetean Mures, Clinica Psihiatrie I
Târgu Mureş, , Romania
Spitalul Clinic Judetean de Urgenta Timisoara, Sectia Clinica de Psihiatrie "eduard Pamfil"
Timișoara, , Romania
Healthcare Institution "Moscow Regional Mental Hospital #5"
Orekhovo-Zuyevo, Moscow Oblast, Russia
State Healthcare Institution <Arkhangelsk Regional Clinical Psychiatric Hospital>
Arkhangelsk, , Russia
State Healthcare Institution "Regional Clinical Specialized Psychoneurological Hospital #1"
Chelyabinsk, , Russia
State Educational Institution of High Professional Education "Chita State Medical Academy of Roszdrav"
Chita, , Russia
St. Petersburg State Healthcare Institution "Mental Hospital #1 named after P.P Kashchenko"
Gatchina, , Russia
St. Petersburg State Healthcare Institution "St. Nicholas the Wonderworker Mental Hospital"
Saint Petersburg, , Russia
Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Ministry of Health and Social Development of the Russian Federation, Department of biological therapy of mental patients
Saint Petersburg, , Russia
State institution "St. Petersburg scientifis-research psychoneurologic Institute of RosZdrav named after V.M Bekhterev"
Saint Petersburg, , Russia
Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Minitstry of Health and Social Development of the Russian Federation
Saint Petersburg, , Russia
St. Petersburg State Healthcare Institution "City Mental Hospital #6 (hospital and Dispensary)"
Saint Petersburg, , Russia
St. Petersburg State Healthcare Institution "City Mental Hospital #3 named after I.I Skvortsov-Stepanov", department #7
Saint Petersburg, , Russia
Municipal Healthcare Institution "City Clinical Hospital #2 named after V.I Razumovsky"
Saratov, , Russia
State Healthcare Institution "Saratov Saint Sophia Regional Mental Hospital"
Saratov, , Russia
Regional State Healthcare Institution "Tomsk Clinical Mental Hospital"
Tomsk, , Russia
Communal Institution of Kyiv Regional Council: Regional Psychiatric-Narcological Medical Association, Department #2 and #14
Village Glevakha, Kyiv Oblast, Ukraine
I.I. Mecnikov Regional Clinical Hospital, Regional Center of Psychosomatic Pathology
Dnipropetrovsk, , Ukraine
Ukraine State Scientific and Research Institute of Medical and Social Problems of Disabiolity, Department of Psychoneurology, Psychotherapy and Medical Psychology
Dnipropetrovsk, , Ukraine
Regional Clinical Psychiatric Hospital Department #11, M. Gorkyy Donetsk National Medical University, Chair of Psychiatry and Medical Psychology
Donetsk, , Ukraine
Kharkiv Regional Clinical Psychiatric Hospital #3, Department #4, Department #14
Kharkiv, , Ukraine
State Institution: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Department of Borderline Psychic Pathology
Kharkiv, , Ukraine
Kherson Regional Psychiatric Hospital, Department #3
Kherson, , Ukraine
Kyiv City Clinical Psychoneurological Hospital #1, Center of Novel Treatment Methods and Rehabilitation of Psychotic Conditions
Kyiv, , Ukraine
Communal Institution: Lviv Regional Clinical Psychiatric Hospital, Department #3 (male), Department #10 (female)
Lviv, , Ukraine
O.F. Maltsev Poltava Regional Clinical Psychiatric Hopspital, Department #3B, State Institution of Higher Education of Ukraine: Ukranian Medical Stomatological Academy, Chair of Psychiatry, Narcology and Medical Psychology
Poltava, , Ukraine
Crimean Republican Institution: Clinical Psychiatric Hospital #1, Female Psychiatric Department #2, Male Psychiatric Department #1, S.I. Georgiyevskyy Crimean State Medical University, Chair of Psychiatry, Psychotherapy and Narcology
Simferopol, , Ukraine
O.I. Yuschenko Vinnytsya Regional Psychoneurological Hospital, Department #10, Department #14, M.I. Pyrogov Vinnytsya National Medical University, Chair of Psychiatry and Narcology
Vinnytsia, , Ukraine
Countries
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References
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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.
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.
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.
Durgam S, Cutler AJ, Lu K, Migliore R, Ruth A, Laszlovszky I, Nemeth G, Meltzer HY. Cariprazine in acute exacerbation of schizophrenia: a fixed-dose, phase 3, randomized, double-blind, placebo- and active-controlled trial. J Clin Psychiatry. 2015 Dec;76(12):e1574-82. doi: 10.4088/JCP.15m09997.
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.
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.
Other Identifiers
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RGH-MD-04
Identifier Type: -
Identifier Source: org_study_id
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