This study is a prospective, observational, single-arm, open-label, multicenter, real-world study conducted in Chinese adult participants with schizophrenia who meet the International Classification of Diseases (ICD)-10 diagnostic criteria. The total study duration is up to 17 weeks, including a screening/baseline data collection period followed by an observational part during which KarXT treatmentpattern, schizophrenia treatment decisions and compliance will be observed in the real-world setting.
Study Type
OBSERVATIONAL
Enrollment
250
Participants will receive KarXT for a treatment/observation period of 17 weeks. The recommended dosage and administration of KarXT should refer to the prescribing information: The recommended starting dosage is one 50 mg/20 mg capsule orally twice daily for at least two days, then increase to one 100 mg/20 mg capsule orally twice daily for at least five days, the dosage may be increased to one 125 mg/30 mg capsule orally twice daily based on participant tolerability and response. All participants who are increased to 125 mg/30 mg, depending on clinician's decision, will have the option to return to 100 mg/20 mg for the remainder of the treatment/observation period. Maintenance doses may be set at 125 mg/30 mg or 100 mg/20 mg twice daily.
KarXTtreatment pattern according to clinicians'decision
Treatment duration (days)for each doseof KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 17
Time frame: through Week 17
KarXTtreatment pattern according to clinicians'decision
Proportion(%)of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) at Week 17
Time frame: Week 17
KarXT Safety Profile
Proportion (%)of KarXT-related adverse events (TRAEs) through Week 17
Time frame: through Week 17
KarXT Treatment PatternAccording to Clinicians'Decision
Treatment duration (days) for each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5
Time frame: through Week 5
KarXT Safety Profile
Proportion (%)of serious adverse events (SAEs) through Week 17
Time frame: through Week 17
KarXT Treatment Effectiveness
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 17
Time frame: Week 17
KarXT Treatment Effectiveness
Change from baseline in the Clinical Global Impression-Severity (CGI-S) score at Week 17
Time frame: Week 17
Schizophrenia Treatment Decisions and Compliance in the Real-world Setting
Proportion (%) of participants discontinuing KarXT treatment along with the documented reasons for the decision from baseline through Week 17
Time frame: through Week 17
KarXT Treatment PatternAccording to Clinicians'Decision
Proportion (%) of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5
Time frame: through Week 5
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