This study is about testing a medicine called lumateperone for children with Autism Spectrum Disorder (ASD). ASD is a condition that affects how a person communicates and interacts with others. The study will check if the medicine is safe and how the body processes it. The study is Phase 1b, meaning it's one of the early stages of testing the medicine. The research is open-label, which means both the doctors and the participants know what treatment is being given.
To join, kids must be between 5 to less than 13 years old and have a diagnosis of ASD with signs of irritability. They must also have a certain score on tests that measure irritability and overall severity of their condition. A healthy weight based on age and gender is also needed, and they must be able to swallow pills.
Children with other mental health issues, recent suicidal thoughts, or serious heart problems cannot join. Also, if they have a history of severe behavior issues, they might not be able to participate.
- Study involves taking medicine and visiting the research center.
- Participants will help researchers learn more about lumateperone.
- Safety checks are important to protect participants.