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Recruiting Phase 3

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

NCT06229210 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2024-01-25
Last updated
2026-11-03

Condition(s) studied

SchizophreniaBipolar DisorderAutism Spectrum Disorder

Investigational drug(s) / intervention(s)

Lumateperone →

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

Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Able to provide consent as follows: * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent; * The patient must provide written assent to study enrollment; * Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder; * Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). * Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study. Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator. Exclusion Criteria: * Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include: * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records. * For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary. * In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or * At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit; * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or * At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or * The patient is considered to be an imminent danger to him/herself or others.

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)

FacilityCityRegionStatus
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.

Official registry record

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