The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.
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).
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.
Parallel
KarXT
DrugSpecified dose on specified days
KarXT Matching Placebo
Other interventionSpecified dose on specified days
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score
Change From Baseline in PANSS Positive Subscale Score
Change From Baseline in PANSS Negative Subscale Score
Change From Baseline in PANSS Marder Negative Factor Score
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