Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Inclusion Criteria:

• Able to provide consent as follows:

• The patient's legally authorized representative (LAR) (eg, parent or guardian)must provide written, informed consent;

• The patient must provide written assent to study enrollment;

• Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male orfemale patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; ormale or female patients aged 5 to 17 years (inclusive) with autism spectrumdisorder;

• Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition TextRevision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, orautism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders andSchizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).

• Is currently an outpatient and is anticipated to maintain outpatient status for theduration of the study.

Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.

Exclusion Criteria:

• Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolarII disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolardisorder with psychotic features are not allowed. Exceptions include:

• ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have beenon a stable treatment regimen of these medication(s) for 30 days prior toScreening. The treatment regimen should remain stable throughout the study.This must be confirmed by the Investigator and noted in the source records.

• For ASD patients only, based on Investigator opinion and DSM-5 criteria, mildor moderate intellectual disability is allowed. Severe or profound intellectualdisability is exclusionary.

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

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

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

• At Screening or Baseline, scores > 3 on Item 13 (suicidal ideation) of theCDRS-R (for bipolar disorder patients only); or

• The patient is considered to be an imminent danger to him/herself or others.