Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Condition(s) studied
Investigational drug(s) / intervention(s)
Lumateperone: Lumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication
Study 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.
Eligibility
Primary outcome measure(s)
- Incidence of Common Adverse Events — Up to 6 months
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Trial sites (65)
| Facility | City | Region | Status |
|---|---|---|---|
| Southwest Autism Research and Resource Center | Phoenix | Arizona | Recruiting |
| Pillar Clinical Research, LLC | Little Rock | Arkansas | Recruiting |
| Advanced Research Center, Inc | Anaheim | California | Recruiting |
| National Institute Of Clinical Research | Garden Grove | California | Recruiting |
| Excell Research Inc | Oceanside | California | Recruiting |
| Inland Psychiatric Medical Group Inc | Redlands | California | Recruiting |
| University Of California - Davis | Sacramento | California | Recruiting |
| University Of California San Diego | San Diego | California | Completed |
| Next Level Clinical Trials, LLC | West Covina | California | Recruiting |
| MCB Clinical Research Centers LLC | Colorado Springs | Colorado | Completed |
| Royal Palm Clinical Research | Fort Myers | Florida | Suspended |
| Sarkis Clinical Trials | Gainesville | Florida | Recruiting |
| United Research Institute | Hialeah | Florida | Recruiting |
| Advanced Research Institute of Miami | Homestead | Florida | Recruiting |
| Green Leaf Clinical Trials | Jacksonville | Florida | Recruiting |
| Vital Care Research | Miami | Florida | Suspended |
| Columbus Clinical Services LLC | Miami | Florida | Recruiting |
| Care Research Center Inc | Miami | Florida | Recruiting |
| Blue Medical Research | Miami | Florida | Recruiting |
| AP Medical Research | Miami | Florida | Suspended |
| Envision Trials LLC | Miami | Florida | Recruiting |
| GTL Medical and Research Group | Miami | Florida | Completed |
| Diverse Clinical Research LLC | Miami | Florida | Recruiting |
| Links Clinical Trials | Miami | Florida | Recruiting |
| New Med Research Inc | Miami Gardens | Florida | Recruiting |
| The Angel Medical Research Corporation | Miami Gardens | Florida | Recruiting |
| Riveldi Biomedical Research | Miami Lakes | Florida | Recruiting |
| APG Research LLC | Orlando | Florida | Suspended |
| Clinical Research Center of Florida | Pompano Beach | Florida | Recruiting |
| University of South Florida Rothman Center of Neuropsychiatry | St. Petersburg | Florida | Recruiting |
| Health Synergy Clinical Research | West Palm Beach | Florida | Recruiting |
| CenExeli Research LLC | Atlanta | Georgia | Recruiting |
| Atlanta Center for Medical Research | Atlanta | Georgia | Recruiting |
| Atlanta Behavioral Research, LLC | Atlanta | Georgia | Completed |
| Salveo Integrative Health Inc | Lawrenceville | Georgia | Completed |
| CenExeli Research LLC 1 | Savannah | Georgia | Recruiting |
| Baber Research Group | Naperville | Illinois | Recruiting |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | Completed |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | Recruiting |
| Midwest Research Group 1 | Saint Charles | Missouri | Recruiting |
+ 25 more sites — see the full list on the official registry below.
More Intra-Cellular Therapies, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06229210 on ClinicalTrials.gov ↗ ← All trials in the USA