Treatment of Bipolar Depression in Children with Lumateperone

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Harmonex Neuroscience Research
  Dothan, Alabama, United States Recruiting
• Pillar Clinical Research, LLC
  Little Rock, Arkansas, United States Recruiting
• Advanced Research Center, Inc
  Anaheim, California, United States Recruiting
• Inland Psychiatric Medical Group Inc
  Redlands, California, United States Recruiting
• UC Davis Health System
  Sacramento, California, United States Recruiting
• Next Level Clinical Trials, LLC
  West Covina, California, United States Recruiting

+18 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.