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KarXT for treating schizophrenia in teens (EMERGENT TEEN)

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age)

Phase 3 Interventional Bristol-Myers Squibb · NCT07288567

This trial will test whether KarXT can help reduce schizophrenia symptoms in adolescents.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment166 (estimated)
Ages13 Years to 17 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations43 sites (Anaheim, California and 42 other locations)
Trial IDNCT07288567 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, double‑blind randomized trial comparing KarXT with a matching placebo in adolescents diagnosed with schizophrenia. Eligibility requires a DSM-5-TR diagnosis confirmed by the K-SADS-PL and moderate-to-severe symptoms (PANSS total ≥70 and CGI-S ≥4 at screening and randomization). Participants will receive either KarXT or placebo and will be followed for changes in symptoms and for safety and tolerability outcomes. The trial is being conducted at outpatient sites in California with regular clinical assessments and adverse event monitoring.

Who should consider this trial

Good fit: Adolescents with a DSM-5-TR diagnosis of schizophrenia confirmed by K-SADS-PL who have moderate-to-severe symptoms (PANSS ≥70 and CGI-S ≥4) and no other primary psychiatric disorder in the prior year are the intended participants.

Not a fit: Young people with mild symptoms, a primary non-schizophrenia psychiatric disorder within the past year, or significant medical conditions that exclude them from the protocol are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, KarXT could provide a new medication option that reduces psychotic symptoms in adolescents and potentially offers a different side-effect profile from existing antipsychotics.

How similar studies have performed: Adult clinical trials of KarXT have shown positive effects on schizophrenia symptoms and acceptable tolerability, but pediatric data are limited and this adolescent study is comparatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Anaheim, California and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Schizophrenia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.