Actively Recruiting
6-Week Study of Cariprazine Treatment for Adolescents Aged 13 to 17 With Schizophrenia
Led by Gedeon Richter Plc. · Updated on 2025-10-08
330
Participants Needed
57
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of cariprazine in treating schizophrenia among adolescents aged 13 to 17 years. This international, multicenter study is designed as a randomized, double-blind, placebo-controlled trial to understand how cariprazine affects symptoms of schizophrenia in this younger population. Participants will be randomly assigned to receive either cariprazine capsules at doses of 1.5 mg or 4.5 mg once daily, or matching placebo capsules once daily. The treatment phase lasts for six weeks, during which participants take the assigned capsules orally every day. During the study, participants will be monitored regularly to assess changes in their schizophrenia symptoms using the Positive and Negative Syndrome Scale PANSS. Researchers will also evaluate safety and tolerability throughout the trial. The main measurement is the change in PANSS total score from the start to the end of the six-week period. The study is designed to last until December 2026.
CONDITIONS
Brief Title
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
Research Team
B
Balázs Lázár
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