RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Intra-Cellular Therapies, Inc. • ClinicalTrials.gov ID: NCT06372964

Registry updated: 2026-09-25

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Description

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).

Interventions

Lumateperone (Drug)
Lumateperone administered orally, once daily.
Placebo (Drug)
Matching placebo administered orally, once daily.

Eligibility 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.

Conditions

Bipolar Depression

Locations

Harmonex Neuroscience Research — Dothan, Alabama, United States
Pillar Clinical Research, LLC — Little Rock, Arkansas, United States
Advanced Research Center, Inc — Anaheim, California, United States
Inland Psychiatric Medical Group Inc — Redlands, California, United States
UC Davis Health System — Sacramento, California, United States
University of California San Diego Medical Center — San Diego, California, United States
Next Level Clinical Trials, LLC — West Covina, California, United States
MCB Clinical Research Centers LLC — Colorado Springs, Colorado, United States
Royal Palm Clinical Research — Fort Myers, Florida, United States
United Research Institute — Hialeah, Florida, United States
Advanced Research Institute of Miami — Homestead, Florida, United States
Vital Care Research — Miami, Florida, United States
Columbus Clinical Services LLC — Miami, Florida, United States
Care Research Center Inc — Miami, Florida, United States
HealthMed Clinical Center Inc — Miami, Florida, United States
Ocean Blue Medical Research Center Inc. — Miami, Florida, United States
AP Medical Research — Miami, Florida, United States
Envision Trials LLC — Miami, Florida, United States
GTL Medical and Research Group — Miami, Florida, United States
Links Clinical Trials — Miami, Florida, United States
SouthGen Clinical Research LLC — Miami, Florida, United States
New Med Research Inc — Miami Gardens, Florida, United States
The Angel Medical Research Corporation — Miami Gardens, Florida, United States
Riveldi Biomedical Research — Miami Lakes, Florida, United States
APG Research LLC — Orlando, Florida, United States
Health Synergy Clinical Research — West Palm Beach, Florida, United States
CenExeli Research LLC — Atlanta, Georgia, United States
Advanced Discovery Research — Atlanta, Georgia, United States
Salveo Integrative Health Inc — Lawrenceville, Georgia, United States
CenExeli Research LLC 1 — Savannah, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
Revive Research Institute — Elgin, Illinois, United States
Indiana University — Indianapolis, Indiana, United States
MTP Psychiatry LLC — Baltimore, Maryland, United States
Neurobehavioral Medicine Group — Bloomfield Hills, Michigan, United States
Midwest Research Group — Saint Charles, Missouri, United States
Washington University School of Medicine Child and Adolescent Psychiatry Clinic — St Louis, Missouri, United States
Alivation Research LLC — Lincoln, Nebraska, United States
NYU Child Study Center — New York, New York, United States
Haidar Almhana Nieding — Avon Lake, Ohio, United States
University of Cincinnati Medical Center — Cincinnati, Ohio, United States
Charak Center for Health and Wellness — Garfield Heights, Ohio, United States
Westlake America Clinic — Westlake, Ohio, United States
SP Research, PLLC (dba Rivus Wellness & Research Institute) — Oklahoma City, Oklahoma, United States
Cutting Edge Research Group — Oklahoma City, Oklahoma, United States
Sooner Clinical Research — Oklahoma City, Oklahoma, United States
The University of Texas at Austin — Austin, Texas, United States
BioBehavioral Research of Austin PC — Austin, Texas, United States
REX Clinical Trials LLC — Beaumont, Texas, United States
North Pointe Psychiatry — Flower Mound, Texas, United States
Kaleidoscope Clinical Research — Houston, Texas, United States
Red Oak Psychiatry Associates — Houston, Texas, United States
Perceptive Pharma Research — Richmond, Texas, United States
Virginia Commonwealth University — Richmond, Virginia, United States
Northwest Clinical Research Center — Bellevue, Washington, United States
Core Clinical Research — Everett, Washington, United States
Centro de Investigaciones y Proyectos en Neurociencias CIPNA — Barranquilla, Colombia
Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO — Bello, Colombia
Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda. — Bogotá, Colombia
Psynapsis Salud Mental S.A. — Pereira, Colombia
Ratandeep Surgical Hospital And Endoscopy Clinic — Ahmedabad, India
Society for Psychiatric Update and Research Shanti Nursing Home — Aurangabad, India
Chopda Medicare & Research Centre — Nashik, India
Deva Institute of Healthcare And Research Pvt Ltd — Varanasi, India
Clinic of Neurology and Psychiatry for Children and Youth — Belgrade, Serbia
Institute of Mental Health Serbia — Belgrade, Serbia
University Clinical Center NIS — Niš, Serbia
Clinical Center of Vojvodina — Novi Sad, Serbia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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