EMERGENT TEEN: KarXT for Schizophrenia in Adolescents

This study is looking at how well and how safely KarXT works for teenagers with schizophrenia. Schizophrenia is a brain disorder that affects how a person thinks, feels, and behaves. You might be able to join if you are 13 to 17 years old and have been diagnosed with schizophrenia based on specific criteria. The study will compare KarXT to a placebo (an inactive substance that looks like the study drug). Researchers will measure changes in your symptoms using a tool called the Positive and Negative Syndrome Scale (PANSS) after 5 weeks. The study plans to enroll 166 participants, but its current status is unclear.

Study design
This is an interventional study comparing KarXT to a placebo. It plans to include 166 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measure of success is taken at Week 5.

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NCT07288567

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)

Recruiting
PHASE3Ages 13–17InterventionalTreatment
Bristol-Myers Squibb
~166 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:KarXTKarXT Matching Placebo

At a glance

Recruiting sites
15 of 39 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Measured over Week 5
Schizophrenia
39 sites across 21 states
Romania6
California4
Texas4
Georgia3
Florida2
Illinois2
Massachusetts2
Colombia2
  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total ScoreWeek 5