Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
NCT06229210
This study is recruiting at 47 US sites in 17 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Schizophrenia
- Bipolar Disorder
- Autism Spectrum Disorder
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Intra-Cellular Therapies, Inc.
- Last updated on ClinicalTrials.gov
- September 25, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 1
- Southwest Autism Research and Resource Center · Phoenix, AZ
Arkansas · 1
- Pillar Clinical Research, LLC · Little Rock, AR
California · 6
- Advanced Research Center, Inc · Anaheim, CA
- National Institute Of Clinical Research · Garden Grove, CA
- Excell Research Inc · Oceanside, CA
- Inland Psychiatric Medical Group Inc · Redlands, CA
- University Of California - Davis · Sacramento, CA
- Next Level Clinical Trials, LLC · West Covina, CA
Florida · 16
- Sarkis Clinical Trials · Gainesville, FL
- United Research Institute · Hialeah, FL
- Advanced Research Institute of Miami · Homestead, FL
- Green Leaf Clinical Trials · Jacksonville, FL
- Blue Medical Research · Miami, FL
- Care Research Center Inc · Miami, FL
- Columbus Clinical Services LLC · Miami, FL
- Diverse Clinical Research LLC · Miami, FL
- Envision Trials LLC · Miami, FL
- Links Clinical Trials · Miami, FL
- New Med Research Inc · Miami Gardens, FL
- The Angel Medical Research Corporation · Miami Gardens, FL
- Riveldi Biomedical Research · Miami Lakes, FL
- Clinical Research Center of Florida · Pompano Beach, FL
- University of South Florida Rothman Center of Neuropsychiatry · St. Petersburg, FL
- Health Synergy Clinical Research · West Palm Beach, FL
Georgia · 3
- Atlanta Center for Medical Research · Atlanta, GA
- CenExeli Research LLC · Atlanta, GA
- CenExeli Research LLC 1 · Savannah, GA
Illinois · 1
- Baber Research Group · Naperville, IL
Michigan · 1
- Neurobehavioral Medicine Group · Bloomfield Hills, MI
Missouri · 1
- Midwest Research Group 1 · Saint Charles, MO
Nebraska · 1
- Alivation Research LLC · Lincoln, NE
Nevada · 1
- Clinical Research of Southern Nevada, LLC · Las Vegas, NV
New York · 2
- NYU Child Study Center · New York, NY
- Richmond Behavioral Associates · Staten Island, NY
Ohio · 2
- University of Cincinnati Medical Center · Cincinnati, OH
- Charak Center for Health and Wellness · Garfield Heights, OH
Oklahoma · 1
- Sooner Clinical Research · Oklahoma City, OK
Tennessee · 1
- Access Clinical Trials · Nashville, TN
Texas · 6
- Texas Research Group · Coppell, TX
- PsyMed Solutions · Fort Worth, TX
- Kaleidoscope Clinical Research · Houston, TX
- Red Oak Psychiatry Associates · Houston, TX
- AIM Trials · Plano, TX
- Perceptive Pharma Research · Richmond, TX
Virginia · 1
- Virginia Commonwealth University · Richmond, VA
Washington · 2
- Northwest Clinical Research Center · Bellevue, WA
- Core Clinical Research · Everett, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.