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

June 1, 2026 updated by: Bristol-Myers Squibb

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

166

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1405BOA
        • Not yet recruiting
        • Local Institution - 0036
        • Contact:
          • Site 0036
      • Córdoba, Argentina, X5003DCE
        • Not yet recruiting
        • Local Institution - 0035
        • Contact:
          • Site 0035
      • Santiago del Estero, Argentina, 4200
        • Not yet recruiting
        • Local Institution - 0102
        • Contact:
          • Site 0102
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1107
        • Not yet recruiting
        • Local Institution - 0084
        • Contact:
          • Site 0084
      • La Plata, Buenos Aires, Argentina, 1900
        • Not yet recruiting
        • Local Institution - 0085
        • Contact:
          • Site 0085
  • Colombia
      • Barranquilla, Colombia, 080020
        • Not yet recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001
      • Bogotá, Colombia, 111166
        • Not yet recruiting
        • Local Institution - 0020
        • Contact:
          • Site 0020
    • Antioquia
      • Bello, Antioquia, Colombia, 051053
        • Not yet recruiting
        • Local Institution - 0109
        • Contact:
          • Site 0109
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 660003
        • Not yet recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
  • Japan
      • Yokohama, Kanagawa, Japan, 213-8507
        • Not yet recruiting
        • Local Institution - 0063
        • Contact:
          • Site 0063
    • Fukuoka
      • Chikugo-Shi, Fukuoka, Japan, 833-0041
        • Not yet recruiting
        • Local Institution - 0075
        • Contact:
          • Site 0075
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 002-8029
        • Recruiting
        • Goryokai Medical Corporation - Goryokai Hospital
        • Contact:
          • Kimihiro Nakajima, Site 0073
          • Phone Number: +81-11-771-5660
    • Kagawa-ken
      • Zentsujichó, Kagawa-ken, Japan, 765-8507
        • Not yet recruiting
        • Local Institution - 0025
        • Contact:
          • Site 0025
    • Miyazaki
      • Miyakonojō, Miyazaki, Japan, 885-0093
        • Not yet recruiting
        • Local Institution - 0062
        • Contact:
          • Site 0062
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Not yet recruiting
        • Local Institution - 0086
        • Contact:
          • Site 0086
      • Ōta-ku, Tokyo, Japan, 1438541
        • Not yet recruiting
        • Local Institution - 0056
        • Contact:
          • Site 0056
  • Romania
      • Bucharest, Romania, 021056
        • Not yet recruiting
        • Local Institution - 0040
        • Contact:
          • Site 0040
      • Bucharest, Romania, 031871
        • Not yet recruiting
        • Local Institution - 0042
        • Contact:
          • Site 0042
      • Iași, Romania, 700282
        • Not yet recruiting
        • Local Institution - 0008
        • Contact:
          • Site 0008
      • Sibiu, Romania, 550082
        • Not yet recruiting
        • Local Institution - 0030
        • Contact:
          • Site 0030
      • Timișoara, Romania, 300329
        • Not yet recruiting
        • Local Institution - 0038
        • Contact:
          • Site 0038
    • Bucharest
      • Bucharest, Bucharest, Romania, 041914
        • Not yet recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400370
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
  • United States
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center Inc.
        • Contact:
          • Steven Macina, Site 0077
          • Phone Number: 714-999-6688
      • Chino, California, United States, 91710
        • Recruiting
        • Inland Psychiatric Medical Group.
        • Contact:
          • Nandita Puchakayala, Site 0058
          • Phone Number: 909-488-9116
      • Culver City, California, United States, 90230
        • Not yet recruiting
        • Local Institution - 0024
        • Contact:
          • Site 0024
      • Redlands, California, United States, 92373
        • Not yet recruiting
        • Local Institution - 0083
        • Contact:
          • Site 0083
      • San Francisco, California, United States, 94158
        • Not yet recruiting
        • Local Institution - 0089
        • Contact:
          • Site 0089
    • Florida
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Apg Research, Llc
        • Contact:
          • Morteza Nadjafi, Site 0032
          • Phone Number: 407-423-7149
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Atlanta Center for Medical Research
        • Contact:
          • Elyssa Barron, Site 0057
          • Phone Number: 404-881-5800
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Salveo Integrative Health - Lawrenceville
        • Contact:
          • Shahzad Hashmi, Site 0106
      • Stone Mountain, Georgia, United States, 30083
        • Recruiting
        • Denali Health Atlanta, LLC
        • Contact:
          • Maria Johnson, Site 0039
    • Illinois
      • Chicago, Illinois, United States, 60622
        • Recruiting
        • EmVenio Research Center - Prime Healthcare
        • Contact:
          • Mitchell Glaser, Site 0044
          • Phone Number: 773-620-2995
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Local Institution - 0076
        • Contact:
          • Site 0076
      • Worcester, Massachusetts, United States, 01608
        • Not yet recruiting
        • Local Institution - 0059
        • Contact:
          • Site 0059
    • New York
      • Great Neck, New York, United States, 11021
        • Not yet recruiting
        • Local Institution - 0061
        • Contact:
          • Site 0061
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience
        • Contact:
          • Melissa DelBello, Site 0051
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Not yet recruiting
        • Local Institution - 0113
        • Contact:
          • Site 0113
    • Texas
      • Garland, Texas, United States, 75043
        • Not yet recruiting
        • Local Institution - 0046
        • Contact:
          • Site 0046
      • Spring, Texas, United States, 77381
        • Not yet recruiting
        • Local Institution - 0066
        • Contact:
          • Site 0066
    • Virginia
      • Richmond, Virginia, United States, 23284
        • Not yet recruiting
        • Local Institution - 0050
        • Contact:
          • Site 0050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: KarXT Matching Placebo
Specified dose on specified days
Experimental: KarXT
Drug: KarXT
Specified dose on specified days
Other Names:
  • BMS-986510

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: Week 5
Week 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score
Time Frame: Week 5
Week 5
Change From Baseline in PANSS Positive Subscale Score
Time Frame: Week 5
Week 5
Change From Baseline in PANSS Negative Subscale Score
Time Frame: Week 5
Week 5
Change From Baseline in PANSS Marder Negative Factor Score
Time Frame: Week 5
Week 5
Number of Participants With PANSS Response
Time Frame: Week 5
PANSS response will be determined by ≥ 30% reduction in PANSS total score.
Week 5
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score
Time Frame: Week 5
Week 5
Change From Baseline in Children's Global Assessment Scale (CGAS)) Score
Time Frame: Week 5
Week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2026

Primary Completion (Estimated)

December 18, 2029

Study Completion (Estimated)

December 18, 2029

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN012-0020
  • 2025-523711-11-00 (Other Identifier: EU CT number)
  • U1111-1325-9936 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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