Safety and Efficacy of Cariprazine in 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)
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria

Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
Patients in their first episode of psychosis
Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
Substance abuse or dependence within the prior 3 months

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Cariprazine (6-9 mg/day)	Cariprazine	Cariprazine once daily fixed-flexible high dose
Cariprazine (3-6 mg/day)	Cariprazine	Cariprazine once daily fixed-flexible low dose

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 score indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Measurement of Schizophrenia Symptoms: 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 score indicates improvement.

Locations (41): Forest Investigative Site 48
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Costa Mesa, California, United States
Forest Investigative Site 50
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Long Beach, California, United States
Forest Investigative Site 42
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Paramount, California, United States
Forest Investigative Site 054
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San Diego, California, United States
Forest Investigative Site 41
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Kissimmee, Florida, United States
Forest Investigative Site 055
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Atlanta, Georgia, United States
Forest Investigative Site 44
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Rockville, Maryland, United States
Forest Investigative Site 45
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Saint Louis, Missouri, United States
Forest Investigative Site 52
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Las Vegas, Nevada, United States
Forest Investigative Site 40
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Cedarhurst, New York, United States
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Forest Investigative Site 48
🇺🇸Costa Mesa, California, United States