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Could a single daily pill help young minds? new trial tests lumateperone for three brain disorders

NCT ID NCT06229210

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial is testing the safety of a medication called lumateperone in children and teenagers who have schizophrenia, bipolar disorder, or autism spectrum disorder. Participants take the drug once daily for 26 weeks, and researchers monitor for side effects. The goal is to see if this treatment is safe for young people with these conditions.

What this could mean

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

Active substance
Lumateperone (a once-daily medication)
What this could lead to
If successful, this could provide a new treatment option for managing symptoms in young people with these conditions.
What could go wrong
This is an early-stage safety study, so it may not show clear benefits. Side effects are possible, and the drug may not work for all participants.

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 300 people

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

Started

Jan 2024

Expected to finish

Apr 2032

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: * Able to provide consent as follows: * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent; * The patient must provide written assent to study enrollment; * Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder; * Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). * Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study. Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator. Exclusion Criteria: * Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include: * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records. * For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary. * 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 * At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or * The patient is considered to be an imminent danger to him/herself or others.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder bipolar disorder bipolar I disorder bipolar II disorder schizophrenia

As listed by the trial registrant

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

Autism spectrum disorder Bipolar disorder Schizophrenia

How to take part

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

  1. The places running it

    56 sites in 3 countries. 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

  • AP Medical Research

    SUSPENDED

    Miami, Florida, 33165, United States

  • APG Research LLC

    SUSPENDED

    Orlando, Florida, 32803, United States

  • Access Clinical Trials

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Advanced Research Center, Inc

    RECRUITING

    Anaheim, California, 92805, United States

  • Advanced Research Institute of Miami

    RECRUITING

    Homestead, Florida, 33033, United States

  • Alivation Research LLC

    RECRUITING

    Lincoln, Nebraska, 68526, United States

  • Atlanta Behavioral Research, LLC

    COMPLETED

    Atlanta, Georgia, 30338, United States

  • Atlanta Center for Medical Research

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Baber Research Group

    RECRUITING

    Naperville, Illinois, 60563, United States

  • Blue Medical Research

    RECRUITING

    Miami, Florida, 33144, United States

  • Care Research Center Inc

    RECRUITING

    Miami, Florida, 33130, United States

  • CenExeli Research LLC

    RECRUITING

    Atlanta, Georgia, 30030, United States

  • CenExeli Research LLC 1

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Charak Center for Health and Wellness

    RECRUITING

    Garfield Heights, Ohio, 44125, United States

  • Clinic of Neurology and Psychiatry for Children and Youth

    RECRUITING

    Belgrade, 11000, Serbia

  • Clinical Center of Vojvodina

    SUSPENDED

    Novi Sad, 21000, Serbia

  • Clinical Research Center of Florida

    RECRUITING

    Pompano Beach, Florida, 33060, United States

  • Clinical Research of Southern Nevada, LLC

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Columbus Clinical Services LLC

    RECRUITING

    Miami, Florida, 33125, United States

  • Core Clinical Research

    RECRUITING

    Everett, Washington, 98201, United States

  • Cutting Edge Research Group

    COMPLETED

    Oklahoma City, Oklahoma, 73116, United States

  • Diverse Clinical Research LLC

    RECRUITING

    Miami, Florida, 33175, United States

  • Envision Trials LLC

    RECRUITING

    Miami, Florida, 33166, United States

  • Excell Research Inc

    RECRUITING

    Oceanside, California, 92056, United States

  • GTL Medical and Research Group

    COMPLETED

    Miami, Florida, 33173, United States

  • Green Leaf Clinical Trials

    RECRUITING

    Jacksonville, Florida, 32258, United States

  • HOMO - ESE Hospital Mental de Antioquia

    RECRUITING

    Bello, 051053, Colombia

  • Health Synergy Clinical Research

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Inland Psychiatric Medical Group Inc

    RECRUITING

    Redlands, California, 92373, United States

  • Institute of Mental Health Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • 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

  • Midwest Research Group 1

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • NYU Child Study Center

    RECRUITING

    New York, New York, 10016, United States

  • National Institute Of Clinical Research

    RECRUITING

    Garden Grove, California, 92844, United States

  • Neurobehavioral Medicine Group

    RECRUITING

    Bloomfield Hills, Michigan, 48302, United States

  • New Med Research Inc

    RECRUITING

    Miami Gardens, Florida, 33056, United States

  • Next Level Clinical Trials, LLC

    RECRUITING

    West Covina, California, 91790, United States

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Perceptive Pharma Research

    RECRUITING

    Richmond, Texas, 77407, United States

  • Pillar Clinical Research, LLC

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • PsyMed Solutions

    RECRUITING

    Fort Worth, Texas, 76132, United States

  • Quest Therapeutics of Avon Lake

    COMPLETED

    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

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Royal Palm Clinical Research

    SUSPENDED

    Fort Myers, Florida, 33901, United States

  • Salveo Integrative Health Inc

    COMPLETED

    Lawrenceville, Georgia, 30046, United States

  • Sarkis Clinical Trials

    RECRUITING

    Gainesville, Florida, 32607, United States

  • Sooner Clinical Research

    RECRUITING

    Oklahoma City, Oklahoma, 73116, United States

  • Southwest Autism Research and Resource Center

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Texas Research Group

    RECRUITING

    Coppell, Texas, 75019, United States

  • The Angel Medical Research Corporation

    RECRUITING

    Miami Gardens, Florida, 33169, United States

  • United Research Institute

    RECRUITING

    Hialeah, Florida, 33012, United States

  • University Clinical Center NIS

    RECRUITING

    Niš, 18000, Serbia

  • University Of California - Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • University Of California San Diego

    COMPLETED

    San Diego, California, 92103, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, 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

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