NCT06372964From ClinicalTrials.govRecruiting

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

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

Bipolar Depression

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Intra-Cellular Therapies, Inc.
Enrolment target: 384
Started: 14 May 2024
Main results due: 31 October 2031
Study sites: 68
Registry updated: 25 September 2026

Can you take part?

Ages 10 years to 17 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(68)

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
University of California San Diego Medical Center
San Diego, California, United States
Completed
Next Level Clinical Trials, LLC
West Covina, California, United States
Recruiting
MCB Clinical Research Centers LLC
Colorado Springs, Colorado, United States
Completed
Royal Palm Clinical Research
Fort Myers, Florida, United States
Suspended
United Research Institute
Hialeah, Florida, United States
Completed
Advanced Research Institute of Miami
Homestead, Florida, United States
Suspended
Vital Care Research
Miami, Florida, United States
Suspended
Columbus Clinical Services LLC
Miami, Florida, United States
Completed
Care Research Center Inc
Miami, Florida, United States
Recruiting
HealthMed Clinical Center Inc
Miami, Florida, United States
Recruiting
Ocean Blue Medical Research Center Inc.
Miami, Florida, United States
Completed
AP Medical Research
Miami, Florida, United States
Suspended
Envision Trials LLC
Miami, Florida, United States
Recruiting
GTL Medical and Research Group
Miami, Florida, United States
Completed
Links Clinical Trials
Miami, Florida, United States
Recruiting
SouthGen Clinical Research LLC
Miami, Florida, United States
Completed
New Med Research Inc
Miami Gardens, Florida, United States
Recruiting
The Angel Medical Research Corporation
Miami Gardens, Florida, United States
Recruiting
Riveldi Biomedical Research
Miami Lakes, Florida, United States
Recruiting
APG Research LLC
Orlando, Florida, United States
Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, United States
Recruiting
CenExeli Research LLC
Atlanta, Georgia, United States
Recruiting
Advanced Discovery Research
Atlanta, Georgia, United States
Completed
Salveo Integrative Health Inc
Lawrenceville, Georgia, United States
Completed
CenExeli Research LLC 1
Savannah, Georgia, United States
Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Recruiting
Revive Research Institute
Elgin, Illinois, United States
Recruiting
Indiana University
Indianapolis, Indiana, United States
Completed
MTP Psychiatry LLC
Baltimore, Maryland, United States
Completed
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States
Recruiting
Midwest Research Group
Saint Charles, Missouri, United States
Recruiting
Washington University School of Medicine Child and Adolescent Psychiatry Clinic
St Louis, Missouri, United States
Completed
Alivation Research LLC
Lincoln, Nebraska, United States
Recruiting
NYU Child Study Center
New York, New York, United States
Recruiting
Haidar Almhana Nieding
Avon Lake, Ohio, United States
Completed
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Recruiting
Charak Center for Health and Wellness
Garfield Heights, Ohio, United States
Recruiting
Westlake America Clinic
Westlake, Ohio, United States
Completed
SP Research, PLLC (dba Rivus Wellness & Research Institute)
Oklahoma City, Oklahoma, United States
Recruiting
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Completed
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Recruiting
The University of Texas at Austin
Austin, Texas, United States
Recruiting
BioBehavioral Research of Austin PC
Austin, Texas, United States
Completed
REX Clinical Trials LLC
Beaumont, Texas, United States
Recruiting
North Pointe Psychiatry
Flower Mound, Texas, United States
Completed
Kaleidoscope Clinical Research
Houston, Texas, United States
Recruiting
Red Oak Psychiatry Associates
Houston, Texas, United States
Completed
Perceptive Pharma Research
Richmond, Texas, United States
Recruiting
Virginia Commonwealth University
Richmond, Virginia, United States
Recruiting
Northwest Clinical Research Center
Bellevue, Washington, United States
Recruiting
Core Clinical Research
Everett, Washington, United States
Recruiting
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, Colombia
Recruiting
Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO
Bello, Colombia
Recruiting
Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
Bogotá, Colombia
Completed
Psynapsis Salud Mental S.A.
Pereira, Colombia
Recruiting

Showing 60 of 68 sites — filter to narrow it down. 37 of the 68 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06372964. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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