KarXT for treating schizophrenia in teens (EMERGENT TEEN)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, double‑blind randomized trial comparing KarXT with a matching placebo in adolescents diagnosed with schizophrenia. Eligibility requires a DSM-5-TR diagnosis confirmed by the K-SADS-PL and moderate-to-severe symptoms (PANSS total ≥70 and CGI-S ≥4 at screening and randomization). Participants will receive either KarXT or placebo and will be followed for changes in symptoms and for safety and tolerability outcomes. The trial is being conducted at outpatient sites in California with regular clinical assessments and adverse event monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• Advanced Research Center Inc.
  Anaheim, California, United States Recruiting
• Inland Psychiatric Medical Group.
  Chino, California, United States Recruiting
• Proscience Research Group
  Culver City, California, United States Recruiting
• UCSF Neurosciences Clinical Research Unit (NCRU)
  San Francisco, California, United States Recruiting
• Apg Research, Llc
  Orlando, Florida, United States Recruiting
• Atlanta Center for Medical Research
  Atlanta, Georgia, United States Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.