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

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia or bipolar disorder.

The study will enroll pediatric patients as follows:

De Novo Patients:

* Patients with schizophrenia, including patients who have previously participated in the lumateperone open-label pediatric pharmacokinetic (PK) study (Study ITI-007-020)
* Patients with bipolar disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-030)

Rollover Patients:

• Patients with bipolar disorder who are enrolling directly from a lead-in efficacy study.

This study will be conducted as follows:

* A Screening Period of up to 2 weeks during which patient eligibility will be assessed.
* A 26-week Open-label Treatment Period (OLTP) during which all patients will receive open-label lumateperone once daily.
* A 2-week Safety Follow-up (SFU) Period: All patients should return to the clinic for the SFU visit approximately 2 weeks after the last dose of open-label lumateperone.

Eligibility Criteria:
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 or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder;
* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia or bipolar I or II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
* Is currently an outpatient and is anticipated to maintain outpatient status for the duration 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 to participate in this study:

* Has a primary psychiatric diagnosis other than schizophrenia or bipolar I or bipolar II disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include:

  * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed 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 suicidal behavior during their participation in the study or

  * At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening 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 years prior 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 criteria for participation in the lead-in study, the Investigator should assess if there has been any change in patient health status. Any newly-emergent medical condition reported during the lead-in study must be evaluated by the Investigator and should be discussed with the Sponsor or designee before enrolling the patient in this study.

Rollover Patients will directly enroll from the lead-in efficacy study at Day 1 of this long-term safety study. Rollover Patients who meet any of the following exclusion criteria will not be eligible to participate in this study:

* The patient is unable to comply with study procedures or judged to be inappropriate for the study, in the opinion of the Investigator
* The patient has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, 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-in study that were considered clinically significant and preclude safe participation in this study, based on the Investigator's clinical judgement.