Wellston

Researchers are evaluating lumateperone for treating irritability in pediatric patients aged 5 to 17 years diagnosed with Autism Spectrum Disorder ASD based on DSM-5-TR criteria and confirmed by K-SADS-PL. This multicenter, randomized, double-blind, placebo-controlled Phase 3 study aims to understand the effects and safety of lumateperone in this population. The study includes three phases a screening period lasting up to 14 days to assess eligibility a 6-week double-blind treatment period where patients are randomly assigned to receive either a high dose of lumateperone 42 mg for ages 13-17, a low dose of lumateperone 21 mg for ages 13-17, or placebo once daily and a safety follow-up visit about one week after the last dose to monitor safety. Participants will attend clinic visits for screening, treatment, and safety follow-up. Researchers will assess irritability using the Aberrant Behavior Checklist - Irritability subscale ABC-I at week 6 as the primary outcome, alongside secondary measures like Clinical Global Impression-Severity CGI-S. Safety and well-being will be monitored throughout, with the entire study lasting approximately 7 weeks from screening to follow-up.