Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
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
1 other identifier
interventional
500
2 countries
50
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Jan 2024
Longer than P75 for phase_3 schizophrenia
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2024
CompletedStudy Start
First participant enrolled
January 25, 2024
CompletedFirst Posted
Study publicly available on registry
January 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
July 8, 2025
July 1, 2025
3.9 years
January 19, 2024
July 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Common Adverse Events
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.
Up to 6 months
Study Arms (1)
Lumateperone
EXPERIMENTALInterventions
Lumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Clinical Site
Phoenix, Arizona, 85006, United States
Clinical Site
Little Rock, Arkansas, 72204, United States
Clinical Site
Anaheim, California, 92805, United States
Clinical Site
Colton, California, 92324, United States
Clinical Site
Garden Grove, California, 92844, United States
Clinical Site
Long Beach, California, 90807, United States
Clinical Site
Redlands, California, 92373, United States
Clinical Site
San Diego, California, 92103, United States
Clinical Site
West Covina, California, 91790, United States
Clinical Site
Colorado Springs, Colorado, 80910, United States
Clinical Site
Gainesville, Florida, 32607, United States
Clinical Site
Hialeah, Florida, 33012, United States
Clinical Site
Miami, Florida, 33122, United States
Clinical Site
Miami, Florida, 33125, United States
Clinical Site
Miami, Florida, 33144, United States
Clinical Site
Miami, Florida, 33165, United States
Clinical Site
Miami, Florida, 33173, United States
Clinical Site
Miami, Florida, 33175, United States
Clinical Site
Miami, Florida, 33176, United States
Clinical Site
Miami Gardens, Florida, 33056, United States
Clinical Site
Miami Lakes, Florida, 33014, United States
Clinical Site
Miami Lakes, Florida, 33016, United States
Clinical Site
Miami Springs, Florida, 33166, United States
Clinical Site
Orlando, Florida, 32803, United States
Clinical Site
Pompano Beach, Florida, 33060, United States
Clinical Site
West Palm Beach, Florida, 33407, United States
Clinical Site
Atlanta, Georgia, 30331, United States
Clinical Site
Decatur, Georgia, 30030, United States
Clinical Site
Lawrenceville, Georgia, 30046, United States
Clinical Site
Savannah, Georgia, 31405, United States
Clinical Site
Naperville, Illinois, 60563, United States
Clinical Site
Indianapolis, Indiana, 46202, United States
Clinical Site
Bloomfield Hills, Michigan, 48302, United States
Clinical Site
Saint Charles, Missouri, 63304, United States
Clinical Site
Lincoln, Nebraska, 68526, United States
Clinical Site
Las Vegas, Nevada, 89128, United States
Clinical Site
Avon Lake, Ohio, 44012, United States
Clinical Site
Cincinnati, Ohio, 45219, United States
Clinical Site
Garfield, Ohio, 44125, United States
Clinical Site
Oklahoma City, Oklahoma, 73116, United States
Clinical Site
Fort Worth, Texas, 76132, United States
Clinical Site
Houston, Texas, 77090, United States
Clinical Site
Plano, Texas, 75093, United States
Clinical Site
Richmond, Texas, 77407, United States
Clinical Site
Richmond, Virginia, 232220, United States
Clinical Site
Bellevue, Washington, 98007, United States
Clinical Site
Everett, Washington, 98201, United States
Clinical Site
Belgrade, 11000, Serbia
Clinical Site
Niš, 18000, Serbia
Clinical Site
Novi Sad, 21000, Serbia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2024
First Posted
January 29, 2024
Study Start
January 25, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
July 8, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share