NCT07379827招募中不适用
Effectiveness and Adverse-effect Switch Evaluation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 61
- 主要终点
- Treatment titration and switch regimens as described by the prescribing clinician
研究概览
简要总结
The purpose of this study is to describe real-world treatment patterns, effectiveness and adverse events of adults diagnosed with schizophrenia that have initiated xanomeline and trospium chloride (KarXT) treatment in the United States
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants (or caregiver/legal guardian) must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICF or signed an electronic ICF in accordance with regulatory, local, and institutional guidelines.
- •Adults ≥ 18 years of age at Baseline who are willing and able, in the judgement of the treating clinician, to participate in routine clinical care and follow up.
- •Schizophrenia, confirmed by the treating clinician's judgement or physician decision to treat the patient with receiving xanomeline and trospium chloride (KarXT) for schizophrenia made prior to and independently of participation in this study. Current Antipsychotic Treatment: Participant must fall into one of the categories below:
- •Be within <16 weeks of initiating treatment with KarXT with intent to discontinue prior antipsychotic treatment(s) OR
- •On a stable regimen (dose and frequency consistent with the drug label and/or at a stable dose based on the judgement of the Investigator for at least 30 days prior to screening) of treatment with 1 or more antipsychotics with plan to discontinue and switch to treatment with KarXT from a prior antipsychotic treatments(s). NOTE: The decision to switch for reasons of safety, tolerability, and/or efficacy will be made independently by the treating clinician and/or the patient and is not dictated by the study. Participants can be enrolled during tapering/discontinuing process from prior antipsychotic treatment(s). Individuals who are not currently receiving treatment for schizophrenia are not eligible for the study. Any antipsychotic treatments must be recorded as concomitant medications.
- •Concomitant psychiatric medications (eg, antidepressants, mood stabilizers, anxiolytics) are permitted and are recommended to remain at a stable dose during the study period.
排除标准
- •Prior use of KarXT that has been discontinued for any reason prior to Baseline.
- •Participation in an interventional study within the last 30 days or plans to participate in an interventional study at the time of eligibility or baseline through the study period.
- •Known hypersensitivity to xanomeline or trospium chloride, or history or high risk of urinary retention, gastric retention, moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment, or narrow-angle glaucoma.
- •In the opinion of the treating clinician, unstable psychiatric or medical conditions that would prevent the participant from safely switching to KarXT. Hospitalized individuals who have been switched to KarXT or are switching treatment to KarXT are permitted to be enrolled at discharge if they are < 16 weeks from initiation of KarXT.
- •Participants who are pregnant, planning to become pregnant, or breastfeeding.
研究组 & 干预措施
Group 1
Participants diagnosed with schizophrenia receiving xanomeline and trospium chloride (KarXT)
干预措施: Xanomeline and trospium chloride (KarXT) (Drug)
结局指标
主要结局
Treatment titration and switch regimens as described by the prescribing clinician
时间窗: Baseline and up to 20 weeks
次要结局
- Adverse events (AEs)(Baseline and up to 20 weeks)
- Change in participant weight(Baseline and up to 20 weeks)
- Clinical Global Impressions - Improvement (CGI-I) score(Baseline and up to 20 weeks)
- Number of schizophrenia-related relapses (defined as schizophrenia-related emergency department visits and/or hospitalizations and symptoms(Baseline and up to 20 weeks)
- Continuation of treatment with xanomeline and trospium chloride (KarXT) at End of Study(Baseline and up to 20 weeks)
- Number of participants who discontinue treatment, time to discontinuation, and reasons for discontinuation(Baseline and up to 20 weeks)
- Number of participants using antiemetic treatment by type, duration, and resolution of event for xanomeline and trospium chloride (KarXT) related gastro-intestinal (GI) symptoms(Baseline and up to 20 weeks)
- Date of first xanomeline and trospium chloride (KarXT) treatment(Baseline)
- Participant age(Baseline)
- Participant sex(Baseline)
- Participant race(Baseline)
- Participant ethnicity(Baseline)
- Participant height(Baseline)
- Participant's family history of schizophrenia(Baseline)
- Duration since diagnosis of schizophrenia(Baseline)
- Previous treatment(s) received for schizophrenia(Baseline)
研究者
研究点 (61)
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