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RecruitingPhase 3

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

Bristol-Myers Squibb · NCT07288567

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 13–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
166
US sites recruiting
13
Study start
January 29, 2026
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: KarXT; KarXT Matching Placebo

Conditions: Schizophrenia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Advanced Research Center Inc.

    Anaheim, CA 92805

    Site contact: Steven Macina, Site 0077 · 714-999-6688

  • Inland Psychiatric Medical Group.

    Chino, CA 91710

    Site contact: Nandita Puchakayala, Site 0058 · 909-488-9116

  • Proscience Research Group

    Culver City, CA 90230

    Site contact: Marina Bussel, Site 0024 · 424-227-8127

  • UCSF Neurosciences Clinical Research Unit (NCRU)

    San Francisco, CA 94158

    Site contact: Danai Nyasha Chagwedera, Site 0089 · 415-746-9047

  • Apg Research, Llc

    Orlando, FL 32803

    Site contact: Morteza Nadjafi, Site 0032 · 407-423-7149

  • Atlanta Center for Medical Research

    Atlanta, GA 30331

    Site contact: Elyssa Barron, Site 0057 · 404-881-5800

  • Salveo Integrative Health - Lawrenceville

    Lawrenceville, GA 30046

    Site contact: Shahzad Hashmi, Site 0106

  • Denali Health Atlanta, LLC

    Stone Mountain, GA 30083

    Site contact: Maria Johnson, Site 0039

  • EmVenio Research Center - Prime Healthcare

    Chicago, IL 60622

    Site contact: Mitchell Glaser, Site 0044 · 773-620-2995

  • Boston Children's Hospital

    Boston, MA 02115

    Site contact: Joseph Gonzalez-Heydrich, Site 0076

  • University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience

    Cincinnati, OH 45219

    Site contact: Melissa DelBello, Site 0051

  • VAST Clinical Research

    Garland, TX 75043

    Site contact: Asikaiwe Chima, Site 0046

  • Memorial Hermann

    Houston, TX 77043

    Site contact: Carlin Barnes, Site 0120

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
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A Study to Evaluate the Efficacy and Safety of KarXT for the… (NCT07288567) | Bored Studies