Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Inclusion Criteria:

1. Able to provide consent as follows:

• The Legally Authorized Representative (LAR) must provide written, informedconsent.

• The patient must provide written assent;

2. Male or female patients 10 to 17 years of age, inclusive;

3. Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition TextRevision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with acurrent MDE without psychosis as confirmed by Kiddie Schedule for AffectiveDisorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);

4. Subject has a lifetime history of at least one manic or hypomanic episode.

5. Subject's current major depressive episode is ≥ 4 weeks and less than 12 months induration;

6. CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening andBaseline;

7. Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 [elevated mood] score ≤

2. at Screening and Baseline.

Exclusion Criteria:

1. Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder.Exception includes:

• Attention deficit hyperactivity disorder (ADHD). If a subject is takingmedications for ADHD, they must have been on a stable treatment regimen ofthese medication(s) for 30 days prior to screening and the treatment regimen isexpected to remain stable throughout the study.

2. Intellectual disability based on Investigator opinion and DSM-5 criteria

3. Patient has been hospitalized for a bipolar manic episode within the 30 days priorto randomization;

4. Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score betweenScreening and Baseline visits, or the CDRS-R is below 45 at Baseline;

5. In the opinion of the Investigator, the patient has a significant risk for suicidalbehavior during his/her participation in the study or

6. 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;

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

8. At Screening or Baseline, scores > 3 on Item 13 (suicidal ideation) on theCDRS-R; or

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