Clinical trial NCT01104766: Safety and Efficacy of Cariprazine in Patients With Schizophrenia
Official title: A Double-Blind, Placebo and Active-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
Aripiprazole
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: 617
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)
* 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:

* Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
* 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

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 the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group, Inc.
state: Arkansas
city: Springdale
country: United States
facility: Woodland Research Northwest, LLC
state: Arkansas
city: Escondido
country: United States
facility: Synergy Clinical Research of Escondido
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc
state: California
city: Riverside
country: United States
facility: Clinical Innovations, Inc.
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Littleton
country: United States
facility: Colorado Clinical Trials, Inc.
state: Colorado
city: Washington
country: United States
facility: Comprehensive Clinical Development, Inc.
state: District of Columbia
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Honolulu
country: United States
facility: Hawaii Clinical Research Center
state: Hawaii
city: Chicago
country: United States
facility: Uptown Research Institute, LLC
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Creve Coeur
country: United States
facility: Millennium Psychiatric Associates, LLC
state: Missouri
city: Willingboro
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Willoughby
country: United States
facility: Windsor-Laurelwood Center for Behavioral Medicine
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt Psychiatric Hospital
state: Tennessee
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic, Ltd.
state: Texas
city: Bothell
country: United States
facility: Pacific Institute of Medical Sciences
state: Washington
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Clinica X Psihiatrie
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica III Psihiatrie
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica VIII Psihiatrie
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Psihiatrie III
city: Craiova
country: Romania
facility: Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie
city: Craiova
country: Romania
facility: Spitalul Clinic Militar de Urgenta, 'Dr. Stefan Odobleja' Clinical de Psihiatrie
city: Piatra Neamt
country: Romania
facility: Spitalul Judetean de Urgenta Piatra Neamt
city: Pitesti
country: Romania
facility: Spitalul Judetean de Urgenta Pitesti, Clinica de Psihiatrie
city: Sibiu
country: Romania
facility: Spitalul de Psihiatrie Dr. Gheorghe Preda" Sibiu
city: Targoviste
country: Romania
facility: Spitalul Judetean de Urgenta Targoviste, Sectia Psihiatrie
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean Mures, Clinica Psihiatrie I
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Timisoara, Sectia Clinica de Psihiatrie "eduard Pamfil"
city: Orekhovo-Zuyevo
country: Russian Federation
facility: Healthcare Institution "Moscow Regional Mental Hospital #5"
state: Moscow Region
city: Arkhangelsk
country: Russian Federation
facility: State Healthcare Institution <Arkhangelsk Regional Clinical Psychiatric Hospital>
city: Chelyabinsk
country: Russian Federation
facility: State Healthcare Institution "Regional Clinical Specialized Psychoneurological Hospital #1"
city: Chita
country: Russian Federation
facility: State Educational Institution of High Professional Education "Chita State Medical Academy of Roszdrav"
city: Gatchina
country: Russian Federation
facility: St. Petersburg State Healthcare Institution "Mental Hospital #1 named after P.P Kashchenko"
city: Saratov
country: Russian Federation
facility: Municipal Healthcare Institution "City Clinical Hospital #2 named after V.I Razumovsky"
city: Saratov
country: Russian Federation
facility: State Healthcare Institution "Saratov Saint Sophia Regional Mental Hospital"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution "St. Nicholas the Wonderworker Mental Hospital"
city: St. Petersburg
country: Russian Federation
facility: 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
city: St. Petersburg
country: Russian Federation
facility: State institution "St. Petersburg scientifis-research psychoneurologic Institute of RosZdrav named after V.M Bekhterev"
city: St. Petersburg
country: Russian Federation
facility: 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
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution "City Mental Hospital #6 (hospital and Dispensary)"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution "City Mental Hospital #3 named after I.I Skvortsov-Stepanov", department #7
city: Tomsk
country: Russian Federation
facility: Regional State Healthcare Institution "Tomsk Clinical Mental Hospital"
city: Village Glevakha
country: Ukraine
facility: Communal Institution of Kyiv Regional Council: Regional Psychiatric-Narcological Medical Association, Department #2 and #14
state: Kyiv
city: Dnipropetrovsk
country: Ukraine
facility: I.I. Mecnikov Regional Clinical Hospital, Regional Center of Psychosomatic Pathology
city: Dnipropetrovsk
country: Ukraine
facility: Ukraine State Scientific and Research Institute of Medical and Social Problems of Disabiolity, Department of Psychoneurology, Psychotherapy and Medical Psychology
city: Donetsk
country: Ukraine
facility: Regional Clinical Psychiatric Hospital Department #11, M. Gorkyy Donetsk National Medical University, Chair of Psychiatry and Medical Psychology
city: Kharkiv
country: Ukraine
facility: Kharkiv Regional Clinical Psychiatric Hospital #3, Department #4, Department #14
city: Kharkiv
country: Ukraine
facility: State Institution: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Department of Borderline Psychic Pathology
city: Kherson
country: Ukraine
facility: Kherson Regional Psychiatric Hospital, Department #3
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Psychoneurological Hospital #1, Center of Novel Treatment Methods and Rehabilitation of Psychotic Conditions
city: Lviv
country: Ukraine
facility: Communal Institution: Lviv Regional Clinical Psychiatric Hospital, Department #3 (male), Department #10 (female)
city: Poltava
country: Ukraine
facility: 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
city: Simferopol
country: Ukraine
facility: 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
city: Vinnytsya
country: Ukraine
facility: O.I. Yuschenko Vinnytsya Regional Psychoneurological Hospital, Department #10, Department #14, M.I. Pyrogov Vinnytsya National Medical University, Chair of Psychiatry and Narcology
Study officials:
affiliation: Forest Laboratories
name: Raffaele Migliore, MA
role: STUDY_DIRECTOR
References:
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.
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: 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.
citation: 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.
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: 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.