๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-27

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder (NCT06229210)

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

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Intra-Cellular Therapies, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Southwest Autism Research and Resource Center โ€” Phoenix, Arizona

Age range: 5 Years to 17 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (64 Sites)

Showing the first 25 of 64 sites.

  • Southwest Autism Research and Resource Center โ€” Phoenix, Arizona
  • Pillar Clinical Research, LLC โ€” Little Rock, Arkansas
  • Advanced Research Center, Inc โ€” Anaheim, California
  • National Institute Of Clinical Research โ€” Garden Grove, California
  • Excell Research Inc โ€” Oceanside, California
  • Inland Psychiatric Medical Group Inc โ€” Redlands, California
  • University Of California - Davis โ€” Sacramento, California
  • University Of California San Diego โ€” San Diego, California
  • Next Level Clinical Trials, LLC โ€” West Covina, California
  • MCB Clinical Research Centers LLC โ€” Colorado Springs, Colorado
  • Royal Palm Clinical Research โ€” Fort Myers, Florida
  • Sarkis Clinical Trials โ€” Gainesville, Florida
  • United Research Institute โ€” Hialeah, Florida
  • Advanced Research Institute of Miami โ€” Homestead, Florida
  • Green Leaf Clinical Trials โ€” Jacksonville, Florida
  • Vital Care Research โ€” Miami, Florida
  • Columbus Clinical Services LLC โ€” Miami, Florida
  • Care Research Center Inc โ€” Miami, Florida
  • Blue Medical Research โ€” Miami, Florida
  • AP Medical Research โ€” Miami, Florida
  • Envision Trials LLC โ€” Miami, Florida
  • GTL Medical and Research Group โ€” Miami, Florida
  • Diverse Clinical Research LLC โ€” Miami, Florida
  • Links Clinical Trials โ€” Miami, Florida
  • New Med Research Inc โ€” Miami Gardens, Florida

๐Ÿ“ž Contact the Study Coordinator

Phone: (844) 434-4210

Email: Participate-In-This-Study1@its.jnj.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Schizophrenia clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—