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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06372964

Public ClinicalTrials.gov record NCT06372964. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 8:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT06372964
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Enrollment
384 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
10 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 13, 2024
Primary completion
Oct 30, 2031
Completion
Oct 30, 2031
Last update posted
Aug 27, 2026

2024 – 2031

United States locations

U.S. sites
56
U.S. states
18
U.S. cities
41
Facility City State ZIP Site status
Harmonex Neuroscience Research Dothan Alabama 36303 Recruiting
Pillar Clinical Research, LLC Little Rock Arkansas 72204 Recruiting
Advanced Research Center, Inc Anaheim California 92805 Recruiting
Inland Psychiatric Medical Group Inc Redlands California 92373 Recruiting
UC Davis Health System Sacramento California 95817 Recruiting
University of California San Diego Medical Center San Diego California 92103 Completed
Next Level Clinical Trials, LLC West Covina California 91790 Recruiting
MCB Clinical Research Centers LLC Colorado Springs Colorado 80910 Completed
Royal Palm Clinical Research Fort Myers Florida 33901 Suspended
United Research Institute Hialeah Florida 33012 Completed
Advanced Research Institute of Miami Homestead Florida 33033 Suspended
Vital Care Research Miami Florida 33122 Suspended
Columbus Clinical Services LLC Miami Florida 33125 Suspended
Care Research Center Inc Miami Florida 33130 Recruiting
HealthMed Clinical Center Inc Miami Florida 33134 Recruiting
Ocean Blue Medical Research Center Inc. Miami Florida 33144 Completed
AP Medical Research Miami Florida 33165 Suspended
Envision Trials LLC Miami Florida 33166 Recruiting
GTL Medical and Research Group Miami Florida 33173 Completed
Links Clinical Trials Miami Florida 33176 Recruiting
SouthGen Clinical Research LLC Miami Florida 33186 Completed
New Med Research Inc Miami Gardens Florida 33056 Recruiting
The Angel Medical Research Corporation Miami Gardens Florida 33169 Recruiting
Riveldi Biomedical Research Miami Lakes Florida 33014 Recruiting
APG Research LLC Orlando Florida 32803 Recruiting
Health Synergy Clinical Research West Palm Beach Florida 33407 Recruiting
CenExeli Research LLC Atlanta Georgia 30030 Recruiting
Advanced Discovery Research Atlanta Georgia 30318 Completed
Salveo Integrative Health Inc Lawrenceville Georgia 30046 Completed
CenExeli Research LLC 1 Savannah Georgia 31405 Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 Recruiting
Revive Research Institute Elgin Illinois 60123 Recruiting
Indiana University Indianapolis Indiana 46202 Completed
MTP Psychiatry LLC Baltimore Maryland 21229 Completed
Neurobehavioral Medicine Group Bloomfield Hills Michigan 48302 Recruiting
Midwest Research Group Saint Charles Missouri 63304 Recruiting
Washington University School of Medicine Child and Adolescent Psychiatry Clinic St Louis Missouri 63110 Completed
Alivation Research LLC Lincoln Nebraska 68526 Recruiting
NYU Child Study Center New York New York 10016 Recruiting
Haidar Almhana Nieding Avon Lake Ohio 44012 Completed
University of Cincinnati Medical Center Cincinnati Ohio 45219 Recruiting
Charak Center for Health and Wellness Garfield Heights Ohio 44125 Recruiting
Westlake America Clinic Westlake Ohio 44145 Completed
SP Research, PLLC (dba Rivus Wellness & Research Institute) Oklahoma City Oklahoma 73112 Recruiting
Cutting Edge Research Group Oklahoma City Oklahoma 73116 Completed
Sooner Clinical Research Oklahoma City Oklahoma 73116 Recruiting
The University of Texas at Austin Austin Texas 78701 Recruiting
BioBehavioral Research of Austin PC Austin Texas 78759 Completed
REX Clinical Trials LLC Beaumont Texas 77701 Recruiting
North Pointe Psychiatry Flower Mound Texas 76028 Completed
Kaleidoscope Clinical Research Houston Texas 77089 Recruiting
Red Oak Psychiatry Associates Houston Texas 77090 Recruiting
Perceptive Pharma Research Richmond Texas 77407 Recruiting
Virginia Commonwealth University Richmond Virginia 23220 Recruiting
Northwest Clinical Research Center Bellevue Washington 98007 Recruiting
Core Clinical Research Everett Washington 98201 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06372964, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06372964 live on ClinicalTrials.gov.

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