The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
752
Cariprazine was supplied in capsules.
Change From Baseline to Week 48 in the PANSS Total Score
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.
Time frame: Baseline to Week 48
Change From Baseline to Week 48 in the CGI-S Score
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.
Time frame: Baseline to Week 48
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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
...and 76 more locations