This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.
The patient's LAR must provide written, informed consent.
When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
History or current diagnosis of Rett syndrome or Fragile X syndrome;
In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
Parallel
Lumateperone high dose
DrugLumateperone administered orally once daily
Lumateperone low dose
DrugLumateperone administered orally once daily
Placebo
DrugMatching Placebo administered orally once daily
Aberrant Behavior Checklist - Irritability (ABC-I)
The ABC-I subscale contains 15 items which rate symptoms on a scale ranging from 0 (not at all a problem) to 3 (severe).
Clinical Global Impression-Severity (CGI-S)
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
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