This study is looking at how well lumateperone (at a high or low dose) works to reduce irritability in children and teenagers with Autism Spectrum Disorder (ASD). Participants will be between 5 and 17 years old. You will receive either lumateperone or a placebo (an inactive substance that looks like the study drug). The main goal is to see if lumateperone improves irritability symptoms, which will be measured after 6 weeks using a specific questionnaire called the Aberrant Behavior Checklist - Irritability (ABC-I). The study plans to enroll 160 participants, but its current status is unclear.

Study design

This is a multicenter, randomized, double-blind, placebo-controlled study. Participants will be randomly assigned to one of three groups: lumateperone high dose, lumateperone low dose, or placebo.

What's involved

You would participate in a screening period (up to 14 days), a 6-week treatment period where you take the study drug once daily, and a 1-week safety follow-up visit after your last dose.

Compensation

Not stated in the trial record.

Follow-up

Participants will have a safety follow-up visit approximately 1 week after their last dose of the study drug.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.