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Lumateperone for Irritability in Children with Autism Spectrum Disorder

This study is testing lumateperone, a medication, to see if it can help reduce irritability in children and teenagers with Autism Spectrum Disorder (ASD). Participants, aged 5 to 17, will receive either a high dose of lumateperone, a low dose of lumateperone, or a placebo (an inactive substance that looks like the study drug). The main goal is to measure changes in irritability using a specific questionnaire (Aberrant Behavior Checklist - Irritability, or ABC-I) after 6 weeks. The study plans to enroll 160 patients and is currently in an unclear status regarding recruitment.

Study design
This is a randomized, double-blind, placebo-controlled study involving 160 pediatric patients. Participants will be randomly assigned to one of three groups.
What's involved
You would have a screening period of up to 14 days, followed by 6 weeks of daily oral medication. There will also be a safety follow-up visit about 1 week after the last dose.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a safety follow-up visit approximately 1 week after their last dose of study medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06706674

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

Recruiting
PHASE3Ages 5–17InterventionalTreatment
Intra-Cellular Therapies, Inc.
~160 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Lumateperone high doseLumateperone low dosePlacebo

At a glance

Recruiting sites
28 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Aberrant Behavior Checklist - Irritability (ABC-I)
Measured over Week 6

Conditions

Irritability Associated With Autism Spectrum Disorder

Explore related trials

Autism Spectrum Disorder

NCT06706674

Where you'd take part

This study runs at 40 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advantage Clinical Trials

    The Bronx, New Yorkno site contact published

    Recruiting

  • Alivation Research LLC

    Lincoln, Nebraskano site contact published

    Recruiting

  • APG Research LLC

    Orlando, Floridano site contact published

    Recruiting

  • Baber Research Group

    Naperville, Illinoisno site contact published

    Recruiting

  • Blue Medical Research

    Miami, Floridano site contact published

    Recruiting

  • California Neuroscience Research

    Sherman Oaks, Californiano site contact published

    Recruiting

  • Care Research Center Inc

    Miami, Floridano site contact published

    Recruiting

  • Clinical Research Center of Florida

    Pompano Beach, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Intra-Cellular Therapies, Inc. Clinical Trial · STUDY_DIRECTOR · Intra-Cellular Therapies, Inc.

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Aberrant Behavior Checklist - Irritability (ABC-I)Week 6

    The ABC-I subscale contains 15 items which rate symptoms on a scale ranging from 0 (not at all a problem) to 3 (severe).