This study tests a new medication called **lumateperone** for kids with irritability linked to *Autism Spectrum Disorder* (ASD). ASD is a condition affecting communication and behavior. The study involves three phases: a screening period (up to 14 days), a treatment period (6 weeks), and a safety follow-up (1 week). During the 6-week treatment, kids are randomly given either a high dose, low dose, or no medication (a placebo). A placebo is a pill with no active medicine, used for comparison. The study is double-blind, meaning neither the participants nor the researchers know who is getting which treatment to avoid bias.
Eligible children are aged 13 to 17 and must have ASD with significant irritability. Parents or guardians need to give consent and be involved throughout the study.
- The study lasts for about 9 weeks total, including all phases.
- Participants need to visit the clinic multiple times.
- Participation is key for safety monitoring and effective results.