Characterization and Progression of Minor Phenomena in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Cumulative probability of developing hallucinations or delusions over time
研究概览
简要总结
Parkinson's disease psychosis encompasses a range of symptoms, including minor phenomena, frank hallucinations, and delusions. Minor phenomena include passage hallucinations (fleeting sense of a person, animal or object passing in the periphery), presence hallucinations (feeling of nearby presence), and illusions (misrepresentation of external stimuli). Some forms of PD psychosis may be progressive. The primary objective of this study is to:
- To determine the cumulative probability of developing hallucinations or delusions over time in individuals with PD minor phenomena followed for 36 months.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease (as determined by Movement Disorders Society diagnostic criteria for clinically probable Parkinson's disease)
- •Parkinson's disease minor phenomena
- •≥30 years of age
- •Proficient in English
- •Willing and able to provide informed consent
排除标准
- •Any current or prior history of formed hallucinations or delusions
- •Current or prior treatment with an antipsychotic medication (regardless of indication)
- •Diagnosis of mania with psychotic features, bipolar or related disorder, depression with psychotic features, or a psychotic disorder
- •Unable or unwilling to complete study activities
- •Any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation
结局指标
主要结局
Cumulative probability of developing hallucinations or delusions over time
时间窗: baseline to 36 months
Kaplan-Meier curves will be used to describe the cumulative probability of hallucinations and/or delusions over time. Participants will be determined to have met the primary endpoint if they have hallucinations and/or delusions on the basis of interview or initiate treatment with an antipsychotic medication.
次要结局
未报告次要终点
研究者
Ruth Schneider, MD
Associate Professor
University of Rochester