A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
Overview
- Phase
- Phase 3
- Intervention
- Cariprazine
- Conditions
- Schizophrenia
- Sponsor
- Forest Laboratories
- Enrollment
- 446
- Locations
- 41
- Primary Endpoint
- Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Cariprazine (3-6 mg/day)
Cariprazine once daily fixed-flexible low dose
Intervention: Cariprazine
Cariprazine (6-9 mg/day)
Cariprazine once daily fixed-flexible high dose
Intervention: Cariprazine
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: 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 Outcomes
- Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S)(Baseline to Week 6)