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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Bipolar Depression

In brief

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

Key facts

Study ID

NCT06372964

Run by

Intra-Cellular Therapies, Inc.

People needed

384

Starts

2024-05-14

Expected to finish

2031-10-31

Last updated by the study team

2026-07-31

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide consent as follows:
• The Legally Authorized Representative (LAR) must provide written, informed consent.
• The patient must provide written assent;
• Male or female patients 10 to 17 years of age, inclusive;
• 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);
• Subject has a lifetime history of at least one manic or hypomanic episode.
• Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
• CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
• Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 [elevated mood] score ≤ 2) at Screening and Baseline.

You may not qualify if…

• 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.
• Intellectual disability based on Investigator opinion and DSM-5 criteria
• Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
• 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;
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her 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) on the CDRS-R; or
• The patient is considered to be an imminent danger to him/herself or others.

Where it is running

• Alivation Research LLC — Lincoln, Nebraska, United States (enrolling)
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Midwest Research Group — Saint Charles, Missouri, United States (enrolling)
• NYU Child Study Center — New York, New York, United States (enrolling)
• Next Level Clinical Trials, LLC — West Covina, California, United States (enrolling)
• CenExeli Research LLC — Atlanta, Georgia, United States (enrolling)
• CenExeli Research LLC 1 — Savannah, Georgia, United States (enrolling)
• Revive Research Institute — Elgin, Illinois, United States (enrolling)
• Neurobehavioral Medicine Group — Bloomfield Hills, Michigan, United States (enrolling)
• Advanced Research Center, Inc — Anaheim, California, United States (enrolling)
• Harmonex Neuroscience Research — Dothan, Alabama, United States (enrolling)
• Care Research Center Inc — Miami, Florida, United States (enrolling)
• HealthMed Clinical Center Inc — Miami, Florida, United States (enrolling)
• Inland Psychiatric Medical Group Inc — Redlands, California, United States (enrolling)
• Health Synergy Clinical Research — West Palm Beach, Florida, United States (enrolling)
• Envision Trials LLC — Miami, Florida, United States (enrolling)
• Pillar Clinical Research, LLC — Little Rock, Arkansas, United States (enrolling)
• Links Clinical Trials — Miami, Florida, United States (enrolling)
• UC Davis Health System — Sacramento, California, United States (enrolling)
• New Med Research Inc — Miami Gardens, Florida, United States (enrolling)
• The Angel Medical Research Corporation — Miami Gardens, Florida, United States (enrolling)
• Riveldi Biomedical Research — Miami Lakes, Florida, United States (enrolling)
• APG Research LLC — Orlando, Florida, United States (enrolling)
• Charak Center for Health and Wellness — Garfield Heights, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.