A Prospective, Observational, Single-Arm, Multicenter Real-World Study Evaluating the Treatment Pattern, Safety and Effectiveness of Xanomeline and Trospium Chloride Capsules (KarXT) in the Treatment of Chinese Adult Participants With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- KarXTtreatment pattern according to clinicians'decision
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants (age: ≥18 and ≤65 years) who meet the ICD-10 diagnostic criteria for schizophrenia.
- •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.
排除标准
- •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.
- •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).
- •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.
- •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.
- •Participants who are pregnant, planning to become pregnant, or breastfeeding.
- •Participants who have any medical conditions that in the investigator's opinion should exclude them from starting KarXT or participate in this study.
研究组 & 干预措施
KarXT Treatment Cohort
The participant is capable of providing written informed consent in this study, agrees to receive KarXT monotherapy
干预措施: Xanomeline and trospium chloride (KarXT) (Drug)
结局指标
主要结局
KarXTtreatment pattern according to clinicians'decision
时间窗: 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
KarXTtreatment pattern according to clinicians'decision
时间窗: Week 17
Proportion(%)of participants on each dose of KarXT (50 mg/20 mg, 100 mg/20 mg, or 125 mg/30 mg) at Week 17
次要结局
- KarXT Safety Profile(through Week 17)
- KarXT Treatment PatternAccording to Clinicians'Decision(through Week 5)
- KarXT Treatment Effectiveness(Week 17)
- Schizophrenia Treatment Decisions and Compliance in the Real-world Setting(through Week 17)