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Treatment of Bipolar Depression in Children with Lumateperone

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years

Phase 3 Interventional Intra-Cellular Therapies, Inc. · NCT06372964

This study is testing if a new medication called lumateperone can help children and teens aged 10 to 17 who are struggling with depression related to bipolar disorder feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment384 (estimated)
Ages10 Years to 17 Years
SexAll
SponsorIntra-Cellular Therapies, Inc. Industry-sponsored
Locations59 sites (Dothan, Alabama and 58 other locations)
Trial IDNCT06372964 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy and safety of lumateperone in pediatric patients aged 10 to 17 who are experiencing major depressive episodes associated with bipolar I or II disorder. The study consists of a screening period, a 6-week treatment phase where participants receive either lumateperone or a placebo, and a safety follow-up period. Eligibility is determined through a structured assessment using the K-SADS-PL to confirm the diagnosis and severity of depression. The study seeks to provide a better treatment option for young patients suffering from bipolar depression.

Who should consider this trial

Good fit: Ideal candidates are male and female patients aged 10 to 17 with a confirmed diagnosis of bipolar I or II disorder experiencing a major depressive episode.

Not a fit: Patients with psychotic features during their depressive episode or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for pediatric patients suffering from bipolar depression.

How similar studies have performed: Other studies have shown promise in treating bipolar depression in adults with similar approaches, but this specific application in pediatric patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Able to provide consent as follows:

   * The Legally Authorized Representative (LAR) must provide written, informed consent.
   * 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 Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders 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 in duration;
6. CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
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 taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected 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 prior to randomization;
4. Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening 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 suicidal behavior during his/her participation in the study or

   1. 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;
   2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
   3. At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) on the CDRS-R; or
   4. The patient is considered to be an imminent danger to him/herself or others.

Where this trial is running

Dothan, Alabama and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bipolar Depression
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.