Schizophrenia Clinical Trials

• 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.

• Able to provide consent as follows:

‣ 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.

• Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);

• ABC-I subscale score of \>18 at Screening and Baseline;

• CGI-S score \> 4 with respect to irritability associated with ASD at Screening and Baseline.