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Treatment of irritability in children with autism using lumateperone

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

Phase 3 Interventional Intra-Cellular Therapies, Inc. · NCT06690398

This study is testing if a medication called lumateperone can help reduce irritability in children with autism, ages 5 to 17.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment174 (estimated)
Ages5 Years to 17 Years
SexAll
SponsorIntra-Cellular Therapies, Inc. Industry-sponsored
Locations37 sites (Dothan, Alabama and 36 other locations)
Trial IDNCT06690398 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy of lumateperone in treating irritability associated with Autism Spectrum Disorder (ASD) in pediatric patients aged 5 to 17 years. The study consists of a screening period to assess eligibility, followed by a 6-week double-blind treatment phase where participants will receive either a high dose, low dose of lumateperone, or a placebo. After treatment, there will be a safety follow-up period to monitor any adverse effects. The study is designed to provide robust data on the safety and effectiveness of lumateperone for this specific condition.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 13 to 17 years diagnosed with irritability associated with Autism Spectrum Disorder.

Not a fit: Patients outside the age range of 5 to 17 years or those without a confirmed diagnosis of irritability associated with Autism Spectrum Disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce irritability in children with Autism Spectrum Disorder, improving their quality of life.

How similar studies have performed: Other studies have shown promise in using similar pharmacological approaches for treating irritability in ASD, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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.
2. Able to provide consent as follows:

   1. The patient's LAR must provide written, informed consent.
   2. When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
3. Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
4. 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);
5. ABC-I subscale score of \>18 at Screening and Baseline;
6. CGI-S score \> 4 with respect to irritability associated with ASD at Screening and Baseline.

Exclusion Criteria:

1. Has a primary psychiatric diagnosis other than ASD. Exceptions include:

   1. 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.
   2. Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
2. History or current diagnosis of Rett syndrome or Fragile X syndrome;
3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or

   1. 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;
   2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
   3. The patient is considered to be an imminent danger to themselves or others.

Where this trial is running

Dothan, Alabama and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Irritability Associated With Autism Spectrum Disorder
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.