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Could a new pill ease irritability in kids with autism?

NCT ID NCT06706674

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 4 times

Summary

This study tests whether the drug lumateperone can safely reduce irritability in children aged 5 to 17 with autism spectrum disorder. Participants receive either a high or low dose of lumateperone or a placebo daily. The main goal is to see if the drug improves irritability scores compared to placebo.

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 effective, lumateperone could offer a new medication option to help manage irritability in children with autism.
What could go wrong
This is a phase 3 trial, but results may not apply to all children. Side effects are possible, and the drug may not work better than placebo.

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

Dec 2024

Expected to finish

Jun 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 (CSSRS) 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

    33 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

  • AP Medical Research

    SUSPENDED

    Miami, Florida, 33165, United States

  • APG Research LLC

    RECRUITING

    Orlando, Florida, 32803, United States

  • Advanced Discovery Research

    COMPLETED

    Atlanta, Georgia, 30318, United States

  • Advanced Research Institute of Miami

    SUSPENDED

    Homestead, Florida, 33033, United States

  • Advantage Clinical Trials

    RECRUITING

    The Bronx, New York, 10467, United States

  • Alivation Research LLC

    RECRUITING

    Lincoln, Nebraska, 68526, United States

  • Baber Research Group

    RECRUITING

    Naperville, Illinois, 60563, United States

  • BioBehavioral Research of Austin PC

    COMPLETED

    Austin, Texas, 78759, United States

  • Blue Medical Research

    RECRUITING

    Miami, Florida, 33144, United States

  • California Neuroscience Research

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • Care Research Center Inc

    RECRUITING

    Miami, Florida, 33130, United States

  • Clinical Research Center of Florida

    RECRUITING

    Pompano Beach, Florida, 33060, United States

  • Core Clinical Research

    RECRUITING

    Everett, Washington, 98201, United States

  • EmVenio Research at Chicago

    RECRUITING

    Chicago, Illinois, 60622, United States

  • Future Search Trials of Dallas

    COMPLETED

    Dallas, Texas, 75251, United States

  • GTL Medical and Research Group

    COMPLETED

    Miami, Florida, 33173, United States

  • Louisiana State University Health Sciences Center Shreveport

    RECRUITING

    Shreveport, Louisiana, 71101, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • NYU Child Study Center

    RECRUITING

    New York, New York, 10016, United States

  • Nathan Kline Institute

    RECRUITING

    Orangeburg, New York, 10962, United States

  • Neurobehavioral Medicine Group

    RECRUITING

    Bloomfield Hills, Michigan, 48302, United States

  • New Med Research Inc

    RECRUITING

    Miami Gardens, Florida, 33056, United States

  • North Texas Clinical Trials

    SUSPENDED

    Fort Worth, Texas, 76104, United States

  • Orlando Psychiatric Associates

    COMPLETED

    Orlando, Florida, 32809, United States

  • Pillar Clinical Research, LLC

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Quest Therapeutics of Avon Lake

    RECRUITING

    Avon Lake, Ohio, 44012, United States

  • Red Oak Psychiatry Associates

    RECRUITING

    Houston, Texas, 77090, United States

  • Richmond Behavioral Associates

    RECRUITING

    Staten Island, New York, 10314, United States

  • Riley Hospital for Children at Indiana University Health

    COMPLETED

    Indianapolis, Indiana, 46202, United States

  • Riveldi Biomedical Research

    SUSPENDED

    Miami Lakes, Florida, 33014, United States

  • SP Research, PLLC (dba Rivus Wellness & Research Institute)

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • Salveo Integrative Health Inc

    COMPLETED

    Lawrenceville, Georgia, 30046, United States

  • Sooner Clinical Research

    RECRUITING

    Oklahoma City, Oklahoma, 73116, United States

  • Texas Research Group

    RECRUITING

    Coppell, Texas, 75019, United States

  • United Research Institute

    RECRUITING

    Hialeah, Florida, 33012, United States

  • University Of California - Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • University of South Florida Rothman Center of Neuropsychiatry

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23220, United States

  • Vital Care Research

    SUSPENDED

    Miami, Florida, 33122, United States

  • Yale University School Of Medicine

    RECRUITING

    New Haven, Connecticut, 06519, United States

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