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

RecruitingPhase 3

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)

Who can join

Ages 13 to 17 · All sexes

Full eligibility 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.

About the study

The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 166 · Started: Jan 29, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07288567

Locations in the U.S.

CaliforniaAdvanced Research Center Inc., Anaheim
Inland Psychiatric Medical Group., Chino
Proscience Research Group, Culver City
UCSF Neurosciences Clinical Research Unit (NCRU), San Francisco
FloridaLocal Institution - 0119, Hollywood (Not yet recruiting)
Apg Research, Llc, Orlando
GeorgiaAtlanta Center for Medical Research, Atlanta
Salveo Integrative Health - Lawrenceville, Lawrenceville
Denali Health Atlanta, LLC, Stone Mountain
IllinoisEmVenio Research Center - Prime Healthcare, Chicago
Local Institution - 0122, Chicago (Not yet recruiting)
MassachusettsBoston Children's Hospital, Boston
Local Institution - 0059, Worcester (Not yet recruiting)
New YorkLocal Institution - 0061, Great Neck (Not yet recruiting)
OhioUniversity of Cincinnati Dept of Psychiatry and Behavioral Neuroscience, Cincinnati
TennesseeLocal Institution - 0113, Nashville (Not yet recruiting)
TexasVAST Clinical Research, Garland
Local Institution - 0120, Houston (Not yet recruiting)
Local Institution - 0066, Spring (Not yet recruiting)
VirginiaLocal Institution - 0050, Richmond (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.