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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT07288567

Run by

Bristol-Myers Squibb

People needed

166

Starts

2026-01-29

Expected to finish

2029-12-18

Last updated by the study team

2026-07-20

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Advanced Research Center Inc. — Anaheim, California, United States (enrolling)
• Inland Psychiatric Medical Group. — Chino, California, United States (enrolling)
• Apg Research, Llc — Orlando, Florida, United States (enrolling)
• Atlanta Center for Medical Research — Atlanta, Georgia, United States (enrolling)
• Salveo Integrative Health - Lawrenceville — Lawrenceville, Georgia, United States (enrolling)
• Denali Health Atlanta, LLC — Stone Mountain, Georgia, United States (enrolling)
• EmVenio Research Center - Prime Healthcare — Chicago, Illinois, United States (enrolling)
• University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience — Cincinnati, Ohio, United States (enrolling)
• VAST Clinical Research — Garland, Texas, United States (enrolling)
• Goryokai Medical Corporation - Goryokai Hospital — Sapporo, Hokkaido, Japan (enrolling)
• Cluj Napoca Emergency Hospital for Children, Department of Pediatric Psychiatry — Cluj-Napoca, Romania (enrolling)
• Emergency Clinical Hospital For Children Louis Turcanu Timis — Timișoara, Romania (enrolling)
• Local Institution - 0059 — Worcester, Massachusetts, United States
• Local Institution - 0061 — Great Neck, New York, United States
• Local Institution - 0042 — Bucharest, Romania
• Local Institution - 0113 — Nashville, Tennessee, United States
• Local Institution - 0030 — Sibiu, Romania
• Local Institution - 0120 — Houston, Texas, United States
• Local Institution - 0118 — Plano, Texas, United States
• Local Institution - 0066 — Spring, Texas, United States
• Local Institution - 0050 — Richmond, Virginia, United States
• Local Institution - 0109 — Bello, Antioquia, Colombia
• Local Institution - 0009 — Pereira, Risaralda Department, Colombia
• Local Institution - 0001 — Barranquilla, Colombia
• Local Institution - 0020 — Bogotá, Colombia

Full record on ClinicalTrials.gov

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