Actively Recruiting

Phase 3
Age: 13Years - 17Years
All Genders
NCT07288567

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

Led by Bristol-Myers Squibb · Updated on 2026-05-11

166

Participants Needed

43

Research Sites

202 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 13Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of schizophrenia confirmed by DSM-5-TR criteria and K-SADS-PL
  • Experiencing symptoms of psychosis at screening
  • PANSS total score of at least 70 at screening and randomization
  • CGI-S score of 4 or higher at screening and randomization
  • Age between 13 and 17 years
Not Eligible

You will not qualify if you...

  • Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening
  • History or presence of significant cardiovascular, pulmonary, liver, kidney, blood, gastrointestinal, endocrine, immune, skin, neurological (except Tourette's Syndrome), or cancer diseases
  • Any grade of hepatic impairment (Child-Pugh Class A, B, or C)
  • Known intellectual disability with IQ less than 70 or clinical/social history indicating intellectual disability
  • Neurological disorders except Tourette's Syndrome
  • Stage 2 hypertension as defined by systolic or diastolic blood pressure criteria
  • Other protocol-defined inclusion/exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 43 locations

1

Local Institution - 0077

Anaheim, California, United States, 92805

Not Yet Recruiting

2

Inland Psychiatric Medical Group.

Chino, California, United States, 91710

Actively Recruiting

3

Local Institution - 0024

Culver City, California, United States, 90230

Not Yet Recruiting

4

Local Institution - 0083

Redlands, California, United States, 92373

Not Yet Recruiting

5

Local Institution - 0089

San Francisco, California, United States, 94158

Not Yet Recruiting

6

Apg Research, Llc

Orlando, Florida, United States, 32803

Actively Recruiting

7

Atlanta Center for Medical Research

Atlanta, Georgia, United States, 30331

Actively Recruiting

8

Salveo Integrative Health - Lawrenceville

Lawrenceville, Georgia, United States, 30046

Actively Recruiting

9

Local Institution - 0039

Stone Mountain, Georgia, United States, 30083

Not Yet Recruiting

10

EmVenio Research Center - Prime Healthcare

Chicago, Illinois, United States, 60622

Actively Recruiting

11

Local Institution - 0076

Boston, Massachusetts, United States, 02115

Not Yet Recruiting

12

Local Institution - 0059

Worcester, Massachusetts, United States, 01608

Not Yet Recruiting

13

Local Institution - 0061

Great Neck, New York, United States, 11021

Not Yet Recruiting

14

University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, United States, 45219

Actively Recruiting

15

Local Institution - 0099

Philadelphia, Pennsylvania, United States, 19139

Not Yet Recruiting

16

Local Institution - 0113

Nashville, Tennessee, United States, 37212

Not Yet Recruiting

17

Local Institution - 0046

Garland, Texas, United States, 75043

Not Yet Recruiting

18

Local Institution - 0066

Spring, Texas, United States, 77381

Not Yet Recruiting

19

Local Institution - 0050

Richmond, Virginia, United States, 23284

Not Yet Recruiting

20

Local Institution - 0084

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1107

Not Yet Recruiting

21

Local Institution - 0085

La Plata, Buenos Aires, Argentina, 1900

Not Yet Recruiting

22

Local Institution - 0036

Buenos Aires, Argentina, C1405BOA

Not Yet Recruiting

23

Local Institution - 0035

Córdoba, Argentina, X5003DCE

Not Yet Recruiting

24

Local Institution - 0102

Santiago del Estero, Argentina, 4200

Not Yet Recruiting

25

Local Institution - 0109

Bello, Antioquia, Colombia, 051053

Not Yet Recruiting

26

Local Institution - 0009

Pereira, Risaralda Department, Colombia, 660003

Not Yet Recruiting

27

Local Institution - 0001

Barranquilla, Colombia, 080020

Not Yet Recruiting

28

Local Institution - 0020

Bogotá, Colombia, 111166

Not Yet Recruiting

29

Local Institution - 0075

Chikugo-Shi, Fukuoka, Japan, 833-0041

Not Yet Recruiting

30

Goryokai Medical Corporation - Goryokai Hospital

Sapporo, Hokkaido, Japan, 002-8029

Actively Recruiting

31

Local Institution - 0025

Zentsujichó, Kagawa-ken, Japan, 765-8507

Not Yet Recruiting

32

Local Institution - 0062

Miyakonojō, Miyazaki, Japan, 885-0093

Not Yet Recruiting

33

Local Institution - 0086

Bunkyo-ku, Tokyo, Japan, 113-8431

Not Yet Recruiting

34

Local Institution - 0056

Ōta-ku, Tokyo, Japan, 1438541

Not Yet Recruiting

35

Local Institution - 0063

Yokohama, Kanagawa, Japan, 213-8507

Not Yet Recruiting

36

Local Institution - 0029

Bucharest, Bucharest, Romania, 041914

Not Yet Recruiting

37

Local Institution - 0031

Brasov, Romania, 500063

Not Yet Recruiting

38

Local Institution - 0040

Bucharest, Romania, 021056

Not Yet Recruiting

39

Local Institution - 0042

Bucharest, Romania, 031871

Not Yet Recruiting

40

Local Institution - 0008

Iași, Romania, 700282

Not Yet Recruiting

41

Local Institution - 0030

Sibiu, Romania, 550082

Not Yet Recruiting

42

Local Institution - 0005

Timișoara, Romania, 300011

Not Yet Recruiting

43

Local Institution - 0038

Timișoara, Romania, 300011

Not Yet Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

F

First line of the email MUST contain NCT # and Site #.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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