Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Irritability Associated With Autism Spectrum Disorder

In brief

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).

Key facts

Study ID

NCT06690398

Run by

Intra-Cellular Therapies, Inc.

People needed

160

Starts

2024-11-22

Expected to finish

2027-07-19

Last updated by the study team

2026-07-31

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.
• Able to provide consent as follows:
• The patient's LAR must provide written, informed consent.
• When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
• Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
• Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
• ABC-I subscale score of >18 at Screening and Baseline;
• CGI-S score > 4 with respect to irritability associated with ASD at Screening and Baseline.

You may not qualify if…

• Has a primary psychiatric diagnosis other than ASD. Exceptions include:
• Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
• Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
• History or current diagnosis of Rett syndrome or Fragile X syndrome;
• 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
• The patient is considered to be an imminent danger to themselves or others.

Where it is running

• Northwest Clinical Research Center — Bellevue, Washington, United States (enrolling)
• Southwest Autism Research and Resource Center — Phoenix, Arizona, United States (enrolling)
• Advanced Research Center Inc — Anaheim, California, United States (enrolling)
• Excell Research Inc — Oceanside, California, United States (enrolling)
• Inland Psychiatric Medical Group Inc — Redlands, California, United States (enrolling)
• REX Clinical Trials LLC — Beaumont, Texas, United States (enrolling)
• North Pointe Psychiatry — Flower Mound, Texas, United States (enrolling)
• Kaleidoscope Clinical Research — Houston, Texas, United States (enrolling)
• AIM Trials — Plano, Texas, United States (enrolling)
• Perceptive Pharma Research — Richmond, Texas, United States (enrolling)
• Clinical Research Partners, LLC — Petersburg, Virginia, United States (enrolling)
• Harmonex Neuroscience Research — Dothan, Alabama, United States (enrolling)
• Next Level Clinical Trials, LLC — West Covina, California, United States (enrolling)
• Sarkis Clinical Trials — Gainesville, Florida, United States (enrolling)
• Green Leaf Clinical Trials — Jacksonville, Florida, United States (enrolling)
• Columbus Clinical Services LLC — Miami, Florida, United States (enrolling)
• South Florida Research Phase I-IV — Miami, Florida, United States (enrolling)
• Diverse Clinical Research LLC — Miami, Florida, United States (enrolling)
• Anchor Medical Research LLC — Miami, Florida, United States (enrolling)
• The Angel Medical Research Corporation — Miami Gardens, Florida, United States (enrolling)
• Health Synergy Clinical Research — West Palm Beach, Florida, United States (enrolling)
• CenExeli Research LLC — Savannah, Georgia, United States (enrolling)
• Revive Research Institute — Elgin, Illinois, United States (enrolling)
• UMass Memorial Healthcare — Worcester, Massachusetts, United States (enrolling)
• Midwest Research Group — Saint Charles, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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