Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

Inclusion Criteria:

1. All patients must have a legally authorized representative LAR (eg, parent or legalguardian) who is willing and able to be responsible for the safety and well-being ofthe patient, provide information about the patient's condition, and accompany thepatient to study visits.

2. Able to provide consent as follows:

3. The patient's LAR must provide written, informed consent.

4. When developmentally appropriate based on Investigator judgment, the patientshould provide written assent.

5. Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17years will be eligible for enrollment.

6. Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition TextRevision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule forAffective Disorders and Schizophrenia for School-Age Children-Present and LifetimeVersion (K-SADS-PL);

7. ABC-I subscale score of >18 at Screening and Baseline;

8. CGI-S score > 4 with respect to irritability associated with ASD at Screening andBaseline.

Exclusion Criteria:

1. Has a primary psychiatric diagnosis other than ASD. Exceptions include:

2. Attention Deficit Hyperactivity Disorder (ADHD). If a patient is takingmedication(s) for ADHD, they must be on a stable treatment regimen of thesemedication(s) for 30 days prior to screening and the treatment regimen isexpected to remain stable throughout the study. This must be confirmed by theInvestigator and noted in the source records.

3. Mild and moderate intellectual disability based on Investigator judgment andDSM-5 criteria (severe and profound intellectual disability are excluded).

4. History or current diagnosis of Rett syndrome or Fragile X syndrome;

5. In the opinion of the Investigator, the patient has a significant risk for suicidalbehavior during their participation in the study or

6. At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 ofthe Columbia-Suicide Severity Rating Scale (CSSRS) within 6 months prior toScreening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;

7. At Screening, the patient has had 1 or more suicidal attempts within the 2years prior to Screening; or

8. The patient is considered to be an imminent danger to themselves or others.