NCT03152292终止不适用
Management of Parkinson's Disease Psychosis in Actual Practice (The INSYTE Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 764
- 试验地点
- 69
- 主要终点
- The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice)
研究概览
简要总结
To examine the current disease progression of PDP, the clinical, economic, and humanistic impact of anti-psychotic therapy in the management of the condition in real-world settings, and the burden of the condition on patients and their caregivers
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females ≥ 18 with PDP
- •Ability to understand and read English
- •Patient is willing and able to sign an Informed Consent Form (ICF), or have a Legally Authorized Representative willing and able to consent on the patient's behalf
- •Possess the symptoms commonly associated with PDP, e.g., hallucinations and delusions that cannot be reasonably attributed to other causes
排除标准
- •Patient is unwilling to participate in the non-interventional study
- •Patient is currently participating in or is planning to participate in an investigational clinical trial
结局指标
主要结局
The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice)
时间窗: Approximately 36 months
Describe the safety and effectiveness of antipsychotic therapies and other treatment approaches in the management of PDP. Describe comparative clinical, economic, and humanistic outcomes of treatment approaches for both patients and caregivers, in the context of real-world medical practice settings.
次要结局
未报告次要终点
研究者
研究点 (69)
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