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Recruiting Phase 3 Interventional

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

ClinicalTrials.gov ID: NCT06229210

Public ClinicalTrials.gov record NCT06229210. 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 8, 2026, 6:23 PM EDT

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

Official title

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder

Brief summary

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

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.

Study identification

NCT ID
NCT06229210
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Enrollment
300 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
5 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
Jan 24, 2024
Primary completion
Apr 27, 2032
Completion
Apr 27, 2032
Last update posted
Aug 27, 2026

2024 – 2032

United States locations

U.S. sites
59
U.S. states
19
U.S. cities
46
Facility City State ZIP Site status
Southwest Autism Research and Resource Center Phoenix Arizona 85006 Recruiting
Pillar Clinical Research, LLC Little Rock Arkansas 72204 Recruiting
Advanced Research Center, Inc Anaheim California 92805 Recruiting
National Institute Of Clinical Research Garden Grove California 92844 Recruiting
Excell Research Inc Oceanside California 92056 Recruiting
Inland Psychiatric Medical Group Inc Redlands California 92373 Recruiting
University Of California - Davis Sacramento California 95817 Recruiting
University Of California San Diego 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
Sarkis Clinical Trials Gainesville Florida 32607 Recruiting
United Research Institute Hialeah Florida 33012 Recruiting
Advanced Research Institute of Miami Homestead Florida 33033 Recruiting
Green Leaf Clinical Trials Jacksonville Florida 32258 Recruiting
Vital Care Research Miami Florida 33122 Suspended
Columbus Clinical Services LLC Miami Florida 33125 Recruiting
Care Research Center Inc Miami Florida 33130 Recruiting
Blue Medical Research Miami Florida 33144 Recruiting
AP Medical Research Miami Florida 33165 Suspended
Envision Trials LLC Miami Florida 33166 Recruiting
GTL Medical and Research Group Miami Florida 33173 Completed
Diverse Clinical Research LLC Miami Florida 33175 Recruiting
Links Clinical Trials Miami Florida 33176 Recruiting
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 Suspended
Clinical Research Center of Florida Pompano Beach Florida 33060 Recruiting
University of South Florida Rothman Center of Neuropsychiatry St. Petersburg Florida 33701 Recruiting
Health Synergy Clinical Research West Palm Beach Florida 33407 Recruiting
CenExeli Research LLC Atlanta Georgia 30030 Recruiting
Atlanta Center for Medical Research Atlanta Georgia 30331 Recruiting
Atlanta Behavioral Research, LLC Atlanta Georgia 30338 Completed
Salveo Integrative Health Inc Lawrenceville Georgia 30046 Completed
CenExeli Research LLC 1 Savannah Georgia 31405 Recruiting
Baber Research Group Naperville Illinois 60563 Recruiting
Riley Hospital for Children at Indiana University Health Indianapolis Indiana 46202 Completed
Neurobehavioral Medicine Group Bloomfield Hills Michigan 48302 Recruiting
Midwest Research Group 1 Saint Charles Missouri 63304 Recruiting
Alivation Research LLC Lincoln Nebraska 68526 Recruiting
Clinical Research of Southern Nevada, LLC Las Vegas Nevada 89128 Recruiting
NYU Child Study Center New York New York 10016 Recruiting
Richmond Behavioral Associates Staten Island New York 10314 Recruiting
Quest Therapeutics of Avon Lake 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
Cutting Edge Research Group Oklahoma City Oklahoma 73116 Completed
Sooner Clinical Research Oklahoma City Oklahoma 73116 Recruiting
Access Clinical Trials Nashville Tennessee 37203 Recruiting
Texas Research Group Coppell Texas 75019 Recruiting
PsyMed Solutions Fort Worth Texas 76132 Recruiting
Kaleidoscope Clinical Research Houston Texas 77089 Recruiting
Red Oak Psychiatry Associates Houston Texas 77090 Recruiting
AIM Trials Plano Texas 75093 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 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06229210, 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 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06229210 live on ClinicalTrials.gov.

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