Safety and Efficacy of Cariprazine in Patients With Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Registration Number
- NCT01104766
- Lead Sponsor
- Forest Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 617
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. Aripiprazole 10mg 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. Cariprazine 3mg 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 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.
- Primary Outcome Measures
Name Time Method Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. Baseline to Week 6 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.
- Secondary Outcome Measures
Name Time Method Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Baseline to Week 6 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.
Trial Locations
- Locations (58)
Synergy Clinical Research of Escondido
🇺🇸Escondido, California, United States
Excell Research, Inc
🇺🇸Oceanside, California, United States
Colorado Clinical Trials, Inc.
🇺🇸Littleton, Colorado, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Millennium Psychiatric Associates, LLC
🇺🇸Creve Coeur, Missouri, United States
Windsor-Laurelwood Center for Behavioral Medicine
🇺🇸Willoughby, Ohio, United States
Pacific Institute of Medical Sciences
🇺🇸Bothell, Washington, United States
Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie
🇷🇴Craiova, Romania
Spitalul de Psihiatrie Dr. Gheorghe Preda" Sibiu
🇷🇴Sibiu, Romania
St. Petersburg State Healthcare Institution "City Mental Hospital #6 (hospital and Dispensary)"
🇷🇺St. Petersburg, Russian Federation
Clinical Innovations, Inc.
🇺🇸Riverside, California, United States
Collaborative Neuroscience Network, Inc.
🇺🇸Torrance, California, United States
Florida Clinical Research Center, LLC
🇺🇸Bradenton, Florida, United States
Uptown Research Institute, LLC
🇺🇸Chicago, Illinois, United States
CRI Worldwide, LLC
🇺🇸Willingboro, New Jersey, United States
Claghorn-Lesem Research Clinic, Ltd.
🇺🇸Houston, Texas, United States
Woodland International Research Group, Inc.
🇺🇸Little Rock, Arkansas, United States
Woodland Research Northwest, LLC
🇺🇸Springdale, Arkansas, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Comprehensive Clinical Development, Inc.
🇺🇸Washington, District of Columbia, United States
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
Vanderbilt Psychiatric Hospital
🇺🇸Nashville, Tennessee, United States
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 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 Judetean de Urgenta Targoviste, Sectia Psihiatrie
🇷🇴Targoviste, Romania
Spitalul Clinic Judetean Mures, Clinica Psihiatrie I
🇷🇴Targu Mures, Romania
Healthcare Institution "Moscow Regional Mental Hospital #5"
🇷🇺Orekhovo-Zuyevo, Moscow Region, Russian Federation
Spitalul Clinic Judetean de Urgenta Timisoara, Sectia Clinica de Psihiatrie "eduard Pamfil"
🇷🇴Timisoara, Romania
State Healthcare Institution "Saratov Saint Sophia Regional Mental Hospital"
🇷🇺Saratov, Russian Federation
St. Petersburg State Healthcare Institution "St. Nicholas the Wonderworker Mental Hospital"
🇷🇺St. Petersburg, 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
Municipal Healthcare Institution "City Clinical Hospital #2 named after V.I Razumovsky"
🇷🇺Saratov, Russian Federation
Regional State Healthcare Institution "Tomsk Clinical Mental Hospital"
🇷🇺Tomsk, 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
State institution "St. Petersburg scientifis-research psychoneurologic Institute of RosZdrav named after V.M Bekhterev"
🇷🇺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
Communal Institution of Kyiv Regional Council: Regional Psychiatric-Narcological Medical Association, Department #2 and #14
🇺🇦Village Glevakha, Kyiv, 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
🇺🇦Vinnytsya, Ukraine
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States
Hawaii Clinical Research Center
🇺🇸Honolulu, Hawaii, United States