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临床试验/NCT00752388
NCT00752388已完成不适用

Application of the WHO-5 Well-being Index (WHO-5) as a Screening Instrument for Depression in Parkinson's Disease

Boehringer Ingelheim15 个研究点 分布在 1 个国家目标入组 1,588 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,588
试验地点
15
主要终点
Prevalence of patients with depressive symptoms (based on WHO-5 and MDI) in total and in subgroups

研究概览

简要总结

To assess the predictive value of sequential administration of WHO-5 and MDI (Major Depression Inventory) for the clinical management of Parkinson Disease (PD) patients by

  • determination of the prevalence of depression in PD patients, based on MDI severity categories and the self-rating scale WHO-5, where poor well being was indicated.
  • exploration of influencing factors (PD status, therapeutic status) on the prevalence of MDI depression categories.

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

入选标准

  • PD patients attending one of the participating neurologist practices during 2 fixed weeks in November 2008
  • Idiopathic PD with or without fluctuations
  • Male or female PD patients aged at least 30
  • Ability to reliably complete self-rating scales (WHO-5, MDI) ), according to the physician's judgement.
  • Written informed consent by the patient for study participation.

排除标准

  • PD Patients who only attend the practice to get a prescription and are not seen by the doctor on that day
  • Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems).

结局指标

主要结局

Prevalence of patients with depressive symptoms (based on WHO-5 and MDI) in total and in subgroups

时间窗: day 1

次要结局

  • WHO-5 score and items(day 1)
  • MDI score (for a subgroup of patients with WHO-5 score < 13 or any WHO-5 item rated with 0 or 1)(day 1)
  • Correlation of WHO-5 and MDI (for a subgroup of patients with a WHO-5 score < 13 or any WHO-5 item rated with 0 or 1) in PD patients(day 1)
  • Investigator assessment of the applicability of the WHO-5 for screening for depression in PD patients(day 1)

研究者

申办方类型
Industry

研究点 (15)

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