Overview

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.

Eligibility

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.