Evaluation of the Long-term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia
Overview
- Phase
- Phase 3
- Intervention
- Cariprazine
- Conditions
- Schizophrenia
- Sponsor
- Forest Laboratories
- Enrollment
- 752
- Locations
- 86
- Primary Endpoint
- Change From Baseline to Week 48 in the PANSS Total Score
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients and corresponding caregivers who have provided informed consents 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 electrocardiogram (ECG).
Exclusion Criteria
- •Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.
Arms & Interventions
Cariprazine
Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
Intervention: Cariprazine
Outcomes
Primary Outcomes
Change From Baseline to Week 48 in the PANSS Total Score
Time Frame: Baseline to Week 48
The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.
Secondary Outcomes
- Change From Baseline to Week 48 in the CGI-S Score(Baseline to Week 48)