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Could KarXT be the key to treating teen schizophrenia?

NCT ID NCT07288567

Disease control Sponsor: Bristol-Myers Squibb 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 10 times

Summary

This phase 3 trial is testing whether the drug KarXT can safely and effectively treat schizophrenia in adolescents aged 13 to 17. About 166 teens will receive either KarXT or a placebo, and researchers will track changes in symptoms like delusions and social withdrawal. The goal is to see if KarXT offers a new treatment option for this age group.

What this could mean

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

Active substance
KarXT (also known as BMS-986510)
What this could lead to
If it works, this could offer a new treatment option for teenagers with schizophrenia, potentially easing symptoms like hallucinations and social withdrawal.
What could go wrong
This is still a clinical trial, so it's not proven yet. The drug may not work better than a placebo, and side effects are possible. Results may not apply to all teens.

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 166 people

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

Started

Jan 2026

Expected to finish

Dec 2029

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

13 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: * Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1). * PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2). * Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2). Exclusion Criteria: * Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening. * History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. * All grades of hepatic impairment (mild \[Child-Pugh Class A\], moderate \[Child-Pugh Class B\], and severe \[Child-Pugh Class C\]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability. * Any neurological disorder, except for Tourette's Syndrome. * Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

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

Schizophrenia

How to take part

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

  1. The places running it

    38 sites in 4 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

  • Advanced Research Center Inc.

    RECRUITING

    Anaheim, California, 92805, United States

  • Apg Research, Llc

    RECRUITING

    Orlando, Florida, 32803, United States

  • Atlanta Center for Medical Research

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cabinet Medical Individual Dr Gheorghita Karina Lidia

    RECRUITING

    Bucharest, 031871, Romania

  • Clinica Animedica Bucuresti

    RECRUITING

    Bucharest, 021056, Romania

  • Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry

    RECRUITING

    Cluj-Napoca, 400370, Romania

  • Denali Health Atlanta, LLC

    RECRUITING

    Stone Mountain, Georgia, 30083, United States

  • EmVenio Research Center - Prime Healthcare

    RECRUITING

    Chicago, Illinois, 60622, United States

  • Emergency Clinical Hospital For Children Louis Turcanu Timis

    RECRUITING

    Timișoara, 300329, Romania

  • Goryokai Medical Corporation - Goryokai Hospital

    RECRUITING

    Sapporo, Hokkaido, 002-8029, Japan

  • Inland Psychiatric Medical Group.

    RECRUITING

    Chino, California, 91710, United States

  • Local Institution - 0001

    NOT_YET_RECRUITING

    Barranquilla, 080020, Colombia

  • Local Institution - 0008

    NOT_YET_RECRUITING

    Iași, 700282, Romania

  • Local Institution - 0009

    NOT_YET_RECRUITING

    Pereira, Risaralda Department, 660003, Colombia

  • Local Institution - 0020

    NOT_YET_RECRUITING

    Bogotá, 111166, Colombia

  • Local Institution - 0025

    NOT_YET_RECRUITING

    Zentsujichó, Kagawa-ken, 765-8507, Japan

  • Local Institution - 0029

    NOT_YET_RECRUITING

    Bucharest, Bucharest, 041914, Romania

  • Local Institution - 0030

    NOT_YET_RECRUITING

    Sibiu, 550082, Romania

  • Local Institution - 0050

    NOT_YET_RECRUITING

    Richmond, Virginia, 23284, United States

  • Local Institution - 0056

    NOT_YET_RECRUITING

    Ōta-ku, Tokyo, 1438541, Japan

  • Local Institution - 0059

    NOT_YET_RECRUITING

    Worcester, Massachusetts, 01608, United States

  • Local Institution - 0061

    NOT_YET_RECRUITING

    Great Neck, New York, 11021, United States

  • Local Institution - 0062

    NOT_YET_RECRUITING

    Miyakonojō, Miyazaki, 885-0093, Japan

  • Local Institution - 0063

    NOT_YET_RECRUITING

    Yokohama, Kanagawa, 213-8507, Japan

  • Local Institution - 0066

    NOT_YET_RECRUITING

    Spring, Texas, 77381, United States

  • Local Institution - 0075

    NOT_YET_RECRUITING

    Chikugo-Shi, Fukuoka, 833-0041, Japan

  • Local Institution - 0086

    NOT_YET_RECRUITING

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Local Institution - 0109

    NOT_YET_RECRUITING

    Bello, Antioquia, 051053, Colombia

  • Local Institution - 0113

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37212, United States

  • Local Institution - 0119

    NOT_YET_RECRUITING

    Hollywood, Florida, 33024, United States

  • Local Institution - 0120

    NOT_YET_RECRUITING

    Houston, Texas, 77043, United States

  • Local Institution - 0122

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Proscience Research Group

    RECRUITING

    Culver City, California, 90230, United States

  • Salveo Integrative Health - Lawrenceville

    RECRUITING

    Lawrenceville, Georgia, 30046, United States

  • UCSF Neurosciences Clinical Research Unit (NCRU)

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • VAST Clinical Research

    RECRUITING

    Garland, Texas, 75043, United States

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