Schizophrenia Disorder
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Zai Lab (Shanghai) Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult participants (age: ≥18 and ≤65 years) who meet the ICD-10 diagnostic criteria for schizophrenia. 2. The participant is capable of providing written informed consent in the study, agrees to receive KarXT monotherapy, is willing to follow the protocol-specified follow-up schedule, and signs the informed consent form, or, where applicable, both the participant and the participant's legal guardian sign the informed consent form.
Exclusion criteria
1. Participants who have contraindications listed in the prescribing information: urinary retention, moderate or severe hepatic impairment, gastric retention, history of hypersensitivity to this product or trospium chloride, or untreated narrow-angle glaucoma. 2. Participants who have conditions not recommended in the prescribing information, such as moderate or severe renal impairment, mild hepatic impairment, or active biliary disease (e.g., symptomatic gallstones). 3. Participants diagnosed with treatment-resistant schizophrenia (TRS), defined as having previously received at least two courses of treatment with different antipsychotic medications, with each course administered at an adequate dose, as determined by the investigator based on clinical judgment, for at least 4 weeks, but without response. 4. Participants with severe suicidal ideations. Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS as confirmed by the following: Answers "Yes" on items 4 or 5 (C -SSRS ideation) with the most recent episode occurring within the 2 months before screening, or answers "Yes" to any of the 5 items (C-SSRS behavior) with an episode occurring within the 12 months before screening. Non-suicidal self-injurious behavior is not exclusionary. 5. Participants who are pregnant, planning to become pregnant, or breastfeeding. 6. Participants who have any medical conditions that in the investigator's opinion should exclude them from starting KarXT or participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KarXTtreatment pattern according to clinicians'decision | through Week 17 | Treatment duration (days)for each doseof KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 17 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KarXT Safety Profile | through Week 17 | Proportion (%)of KarXT-related adverse events (TRAEs) through Week 17 |
| KarXT Treatment PatternAccording to Clinicians'Decision | through Week 5 | Treatment duration (days) for each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) through Week 5 |
| KarXT Treatment Effectiveness | Week 17 | Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 17 |
| Schizophrenia Treatment Decisions and Compliance in the Real-world Setting | through Week 17 | Proportion (%) of participants discontinuing KarXT treatment along with the documented reasons for the decision from baseline through Week 17 |
Contacts
CONTACTHua Shi WANG
Outcome results
None listed