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Could a new pill tame Autism-Related irritability in kids?

NCT ID NCT06690398

Symptom relief Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study tests whether the drug lumateperone can safely reduce irritability in children aged 5 to 17 who have autism spectrum disorder. Participants receive either a high dose, low dose, or placebo daily for several weeks. Researchers measure changes in irritability using a standard behavior checklist.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lumateperone
What this could lead to
If successful, this could provide a new medication option to help manage irritability in children with autism, potentially improving daily functioning and quality of life.
What could go wrong
This is a phase 3 trial, but results may not confirm benefit over placebo. Side effects of lumateperone are possible, and what works in a study may not work for every child in real-world settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Irritability associated with autism spectrum disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AIM Trials

    RECRUITING

    Plano, Texas, 75093, United States

  • Access Clinical Trials

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Advanced Research Center Inc

    RECRUITING

    Anaheim, California, 92805, United States

  • Anchor Medical Research LLC

    RECRUITING

    Miami, Florida, 33176, United States

  • Buena Park Research

    COMPLETED

    Upland, California, 91786, United States

  • CenExeli Research LLC

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Charak Center for Health and Wellness

    RECRUITING

    Garfield, Ohio, 44125, United States

  • Clinical Research Partners, LLC

    RECRUITING

    Petersburg, Virginia, 23805, United States

  • Columbus Clinical Services LLC

    RECRUITING

    Miami, Florida, 33125, United States

  • Diverse Clinical Research LLC

    RECRUITING

    Miami, Florida, 33175, United States

  • Excell Research Inc

    RECRUITING

    Oceanside, California, 92056, United States

  • Green Leaf Clinical Trials

    RECRUITING

    Jacksonville, Florida, 32258, United States

  • Harmonex Neuroscience Research

    RECRUITING

    Dothan, Alabama, 36303, United States

  • Health Synergy Clinical Research

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Inland Psychiatric Medical Group Inc

    RECRUITING

    Redlands, California, 92373, United States

  • Kaleidoscope Clinical Research

    RECRUITING

    Houston, Texas, 77089, United States

  • Links Clinical Trials

    RECRUITING

    Miami, Florida, 33176, United States

  • MCB Clinical Research Centers LLC

    COMPLETED

    Colorado Springs, Colorado, 80910, United States

  • Massachusetts General Hospital

    COMPLETED

    Boston, Massachusetts, 02114, United States

  • Midwest Research Group

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • Next Level Clinical Trials, LLC

    RECRUITING

    West Covina, California, 91790, United States

  • North Pointe Psychiatry

    COMPLETED

    Flower Mound, Texas, 76028, United States

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Perceptive Pharma Research

    RECRUITING

    Richmond, Texas, 77407, United States

  • REX Clinical Trials LLC

    RECRUITING

    Beaumont, Texas, 77701, United States

  • Revive Research Institute

    RECRUITING

    Elgin, Illinois, 60123, United States

  • Royal Palm Clinical Research

    SUSPENDED

    Fort Myers, Florida, 33901, United States

  • Sarkis Clinical Trials

    RECRUITING

    Gainesville, Florida, 32607, United States

  • South Florida Research Phase I-IV

    RECRUITING

    Miami, Florida, 33166, United States

  • Southern Illinois University School of Medicine

    SUSPENDED

    Springfield, Illinois, 62701, United States

  • Southwest Autism Research and Resource Center

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • The Angel Medical Research Corporation

    RECRUITING

    Miami Gardens, Florida, 33169, United States

  • UMass Memorial Healthcare

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • Vector Clinical Trials

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Westlake Brain Health

    COMPLETED

    Westlake, Ohio, 44145, United States

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