Safety and Efficacy of Cariprazine in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104766
• Other study ID #: RGH-MD-04
• Status: Completed
• Phase: Phase 3
• Start date: April 23, 2010
• Est. completion date: December 20, 2011

Study information

• Verified date: October 2018
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 617
• Est. completion date: December 20, 2011
• Est. primary completion date: December 20, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Romania	Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Clinica X Psihiatrie	Bucuresti
Romania	Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica III Psihiatrie	Bucuresti
Romania	Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica VIII Psihiatrie	Bucuresti
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 Neamt
Romania	Spitalul Judetean de Urgenta Pitesti, Clinica de Psihiatrie	Pitesti
Romania	Spitalul de Psihiatrie Dr. Gheorghe Preda" Sibiu	Sibiu
Romania	Spitalul Judetean de Urgenta Targoviste, Sectia Psihiatrie	Targoviste
Romania	Spitalul Clinic Judetean Mures, Clinica Psihiatrie I	Targu Mures
Romania	Spitalul Clinic Judetean de Urgenta Timisoara, Sectia Clinica de Psihiatrie "eduard Pamfil"	Timisoara
Russian Federation	State Healthcare Institution <Arkhangelsk Regional Clinical Psychiatric Hospital>	Arkhangelsk
Russian Federation	State Healthcare Institution "Regional Clinical Specialized Psychoneurological Hospital #1"	Chelyabinsk
Russian Federation	State Educational Institution of High Professional Education "Chita State Medical Academy of Roszdrav"	Chita
Russian Federation	St. Petersburg State Healthcare Institution "Mental Hospital #1 named after P.P Kashchenko"	Gatchina
Russian Federation	Healthcare Institution "Moscow Regional Mental Hospital #5"	Orekhovo-Zuyevo	Moscow Region
Russian Federation	Municipal Healthcare Institution "City Clinical Hospital #2 named after V.I Razumovsky"	Saratov
Russian Federation	State Healthcare Institution "Saratov Saint Sophia Regional Mental Hospital"	Saratov
Russian Federation	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	St. Petersburg
Russian Federation	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	St. Petersburg
Russian Federation	St. Petersburg State Healthcare Institution "City Mental Hospital #3 named after I.I Skvortsov-Stepanov", department #7	St. Petersburg
Russian Federation	St. Petersburg State Healthcare Institution "City Mental Hospital #6 (hospital and Dispensary)"	St. Petersburg
Russian Federation	St. Petersburg State Healthcare Institution "St. Nicholas the Wonderworker Mental Hospital"	St. Petersburg
Russian Federation	State institution "St. Petersburg scientifis-research psychoneurologic Institute of RosZdrav named after V.M Bekhterev"	St. Petersburg
Russian Federation	Regional State Healthcare Institution "Tomsk Clinical Mental Hospital"	Tomsk
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	Communal Institution of Kyiv Regional Council: Regional Psychiatric-Narcological Medical Association, Department #2 and #14	Village Glevakha	Kyiv
Ukraine	O.I. Yuschenko Vinnytsya Regional Psychoneurological Hospital, Department #10, Department #14, M.I. Pyrogov Vinnytsya National Medical University, Chair of Psychiatry and Narcology	Vinnytsya
United States	Pacific Institute of Medical Sciences	Bothell	Washington
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Uptown Research Institute, LLC	Chicago	Illinois
United States	Millennium Psychiatric Associates, LLC	Creve Coeur	Missouri
United States	Synergy Clinical Research of Escondido	Escondido	California
United States	Precise Research Centers	Flowood	Mississippi
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Hawaii Clinical Research Center	Honolulu	Hawaii
United States	Claghorn-Lesem Research Clinic, Ltd.	Houston	Texas
United States	Woodland International Research Group, Inc.	Little Rock	Arkansas
United States	Colorado Clinical Trials, Inc.	Littleton	Colorado
United States	Vanderbilt Psychiatric Hospital	Nashville	Tennessee
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	Woodland Research Northwest, LLC	Springdale	Arkansas
United States	Collaborative Neuroscience Network, Inc.	Torrance	California
United States	Comprehensive Clinical Development, Inc.	Washington	District of Columbia
United States	CRI Worldwide, LLC	Willingboro	New Jersey
United States	Windsor-Laurelwood Center for Behavioral Medicine	Willoughby	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Gedeon Richter Ltd.

Countries where clinical trial is conducted

United States,  Romania,  Russian Federation,  Ukraine, 

References & Publications (4)

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. — View Citation

Durgam S, Cutler AJ, Lu K, Migliore R, Ruth A, Laszlovszky I, Németh 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(1 — View 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. — View Citation

Nasrallah HA, Earley W, Cutler AJ, Wang Y, Lu K, Laszlovszky I, Németh 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.	The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.	Baseline to Week 6
Secondary	Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)	The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change from baseline score indicates improvement.	Baseline to Week 6