Safety and Efficacy of Cariprazine in Patients With Schizophrenia

Phase 3

Completed

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.

Recruitment & 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

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.

Locations (58): 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, District of Columbia, United States
Florida Clinical Research Center, LLC
🇺🇸
Bradenton, Florida, United States
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Woodland International Research Group, Inc.
🇺🇸Little Rock, Arkansas, United States