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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)

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
13 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well KarXT works to treat schizophrenia in teens and how safe it is. It is for teens with schizophrenia who currently have symptoms of psychosis, such as trouble knowing what is real.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have schizophrenia confirmed by a study interview, and have symptoms of psychosis at the first screening visit.
  • Score at least 70 on the PANSS, a scale that measures schizophrenia symptoms, at screening and the visit when treatment is assigned.
  • Score at least 4 on the CGI-S, a scale that measures how severe the illness is, at both of those visits.

Who can't join

  • Have had a main mental health diagnosis other than schizophrenia in the 12 months before screening.
  • Have a serious health condition that the study doctor thinks could make the study unsafe for you or affect the results.
  • Have any level of reduced liver function, from mild to severe.
  • Have a known intellectual disability, meaning limits in learning and everyday skills. This includes an IQ below 70 or signs of this disability in medical, social, or school history.
  • Have a brain or nerve disorder other than Tourette's syndrome.
  • Have blood pressure in the stage 2 high blood pressure range, based on either the top or bottom number, even without symptoms.
  • Other study rules for who can join also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (20)

CA

FL

GA

IL

MA

NY

OH

  • University of Cincinnati Dept of Psychiatry and Behavioral Neuroscience · Cincinnati, OH 45219Melissa DelBello, Site 0051 · Study contactMore trials in Cincinnati

TN

TX

VA