Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia

Condition(s) studied

Investigational drug(s) / intervention(s)

Cariprazine: Cariprazine capsules, oral administration, once daily.

Placebo: Matching placebo capsules, oral administration, once daily.

Study summary

The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.

Eligibility

Primary outcome measure(s)

• Change from baseline in PANSS total score at Week 6 — 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 from baseline score indicates improvement.

Trial sites (57)

+ 17 more sites — see the full list on the official registry below.

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