Long-term Study of Cariprazine in Patients With Schizophrenia
- Registration Number
- NCT01104792
- Lead Sponsor
- Forest Laboratories
- Brief Summary
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 752
- 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).
- Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cariprazine Cariprazine Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 48 in the PANSS Total Score 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 Outcome Measures
Name Time Method Change From Baseline to Week 48 in the CGI-S Score Baseline to Week 48 The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.
Trial Locations
- Locations (86)
Forest Investigative Site 072
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 021
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 086
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 014
🇺🇸Springdale, Arkansas, United States
Forest Investigative Site 080
🇺🇸Carson, California, United States
Forest Investigative Site 079
🇺🇸Cerritos, California, United States
Forest Investigative Site 048
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 070
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 022
🇺🇸Garden Grove, California, United States
Forest Investigative Site 083
🇺🇸Garden Grove, California, United States
Scroll for more (76 remaining)Forest Investigative Site 072🇺🇸Little Rock, Arkansas, United States