Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients (NCT06372964)
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
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Harmonex Neuroscience Research — Dothan, Alabama
Age range: 10 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (68 Sites)
Showing the first 25 of 68 sites.
- Harmonex Neuroscience Research — Dothan, Alabama
- Pillar Clinical Research, LLC — Little Rock, Arkansas
- Advanced Research Center, Inc — Anaheim, California
- Inland Psychiatric Medical Group Inc — Redlands, California
- UC Davis Health System — Sacramento, California
- University of California San Diego Medical Center — San Diego, California
- Next Level Clinical Trials, LLC — West Covina, California
- MCB Clinical Research Centers LLC — Colorado Springs, Colorado
- Royal Palm Clinical Research — Fort Myers, Florida
- United Research Institute — Hialeah, Florida
- Advanced Research Institute of Miami — Homestead, Florida
- Vital Care Research — Miami, Florida
- Columbus Clinical Services LLC — Miami, Florida
- Care Research Center Inc — Miami, Florida
- HealthMed Clinical Center Inc — Miami, Florida
- Ocean Blue Medical Research Center Inc. — Miami, Florida
- AP Medical Research — Miami, Florida
- Envision Trials LLC — Miami, Florida
- GTL Medical and Research Group — Miami, Florida
- Links Clinical Trials — Miami, Florida
- SouthGen Clinical Research LLC — Miami, Florida
- New Med Research Inc — Miami Gardens, Florida
- The Angel Medical Research Corporation — Miami Gardens, Florida
- Riveldi Biomedical Research — Miami Lakes, Florida
- APG Research LLC — Orlando, Florida
📞 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.
💰 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 § 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.
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- Brexpiprazole Treatment for Bipolar I Depression — Hamilton, Ontario
- SYNCED - SYNChronized Eating in Bipolar Depression Study — Ottawa, Ontario
- Deep Brain Stimulation of Treatment-Resistant Bipolar Depression — Boston, Massachusetts
- Ketogenic Intervention for Bipolar Depression — Rochester, Minnesota
Explore by condition: All Bipolar Depression clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.