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

September 3, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

  • 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, 031871
        • Recruiting
        • Cabinet Medical Individual Dr Gheorghita Karina Lidia
        • Contact:
          • Karina Gheorghita, Site 0042
          • Phone Number: +40722171504
      • Bucharest, Romania, 021056
        • Recruiting
        • Clinica Animedica Bucuresti
        • Contact:
          • Monica Safer, Site 0040
          • Phone Number: 0722656378
      • Cluj-Napoca, Romania, 400370
        • Recruiting
        • Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry
        • Contact:
          • Elena Predescu, Site 0031
      • 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
        • Recruiting
        • Emergency Clinical Hospital For Children Louis Turcanu Timis
        • Contact:
          • Laura Nussbaum, Site 0038
    • Bucharest
      • Bucharest, Bucharest, Romania, 041914
        • Not yet recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
  • 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
        • Recruiting
        • ProScience Research Group
        • Contact:
          • Marina Bussel, Site 0024
          • Phone Number: 424-227-8127
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Neurosciences Clinical Research Unit (NCRU)
        • Contact:
          • Danai Nyasha Chagwedera, Site 0089
          • Phone Number: 415-861-9288
    • Florida
      • Hollywood, Florida, United States, 33024
        • Not yet recruiting
        • Local Institution - 0119
        • Contact:
          • Site 0119
      • 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
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Local Institution - 0122
        • Contact:
          • Site 0122
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Contact:
          • Joseph Gonzalez-Heydrich, 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
        • Recruiting
        • VAST Clinical Research
        • Contact:
          • Asikaiwe Chima, Site 0046
      • Houston, Texas, United States, 77043
        • Not yet recruiting
        • Local Institution - 0120
        • Contact:
          • Site 0120
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CN012-0020
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 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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