The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
330
Cariprazine capsules, oral administration, once daily.
Matching placebo capsules, oral administration, once daily.
Change from baseline in PANSS total score at 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 from baseline score indicates improvement.
Time frame: Baseline to Week 6
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ProScience Research Group
Culver City, California, United States
COMPLETEDAtlanta Center for Medical Research
Atlanta, Georgia, United States
COMPLETEDAtlanta Behavioral Research, LLC
Atlanta, Georgia, United States
WITHDRAWNBloomfield Hills MI
Bloomfield Hills, Michigan, United States
WITHDRAWNPrecise Research Centers
Flowood, Mississippi, United States
WITHDRAWNUB Department of Psychiatry
Buffalo, New York, United States
WITHDRAWNManhattan Behavioral Medicine PLLC
New York, New York, United States
WITHDRAWNUniversity of Cincinnati
Cincinnati, Ohio, United States
COMPLETEDFamily Psychiatry of The Woodlands
The Woodlands, Texas, United States
COMPLETEDClinic of Child Psychiatry St. Nikolas
Sofia, Bulgaria
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