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

Inclusion Criteria: De Novo Patients must meet the following 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 or male orfemale patients aged 10 to 17 years (inclusive) with bipolar I or II disorder;
• Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition TextRevision (DSM-5-TR) primary diagnosis of schizophrenia or bipolar I or II disorder asconfirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-AgeChildren-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 meet all of the following criteria:
• Must have safely completed the lead-in study, in the opinion of the Investigator
• Able to provide consent as follows:
• The patient's LAR must provide written, informed consent;
• The patient must provide written assent to study enrollment

Exclusion Criteria: De Novo Patients who meet any of the following exclusion criteria will not be eligible toparticipate in this study:

• Has a primary psychiatric diagnosis other than schizophrenia or bipolar I or bipolarII disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic featuresare not allowed. Exceptions include:
• ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been ona stable treatment regimen of these medication(s) for 30 days prior to Screening.The treatment regimen should remain stable throughout the study. This must beconfirmed by the Investigator and noted in the source records.
• Mild intellectual disability based on Investigator opinion and DSM-5 criteria (Moderate and Severe intellectual disability are excluded.
• 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 2 yearsprior to Screening; or
• At Screening or Baseline, scores > 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or
• The patient is considered to be an imminent danger to him/herself or others.Because all Rollover Patients were required to not meet any exclusion criteriafor participation in the lead-in study, the Investigator should assess if therehas been any change in patient health status. Any newly-emergent medicalcondition reported during the lead-in study must be evaluated by the Investigatorand should be discussed with the Sponsor or designee before enrolling the patientin this study. Rollover Patients will directly enroll from the lead-in efficacy study at Day 1 of thislong-term safety study. Rollover Patients who meet any of the following exclusion criteriawill not be eligible to participate in this study:
• The patient is unable to comply with study procedures or judged to be inappropriatefor the study, in the opinion of the Investigator
• The patient has a significant risk for suicidal behavior during the course of her/hisparticipation in the study or is considered to be an imminent danger to her/himself orothers, in the opinion of the Investigator, and/or:
• At the Baseline Visit the patient scores "yes" on Suicidal Ideation Items 3, 4,or 5 of the C-SSRS using the "Since the Last Visit" version (used at Visit 8/Week 6 of the lead in study);
• At the Baseline Visit, scores > 3 on Item 13 (suicidal ideation) of the CDRS-R (based on the Visit 8/Week 6 assessment from the lead in study); or
• The patient is considered to be an imminent danger to him/herself or others.
• The patient had any abnormal clinical laboratory tests results during the lead-instudy that were considered clinically significant and preclude safe participation inthis study, based on the Investigator's clinical judgement.