Safety and Efficacy of Cariprazine in Patients With Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Aripiprazole; Drug: Cariprazine

• 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

Study Timeline

• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Study Start: 2010-04-23
• Primary Completion: 2011-12-20
• Study Completion: 2011-12-20
• Disposition First Submitted: 2011-12-30
• Disposition First Submitted QC: 2011-12-30
• Disposition First Posted: 2012-01-04
• Results First Submitted: 2018-06-14
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-26
• Last Update Submitted: 2018-10-26
• Results First Posted: 2018-10-29
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 617

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

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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

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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