NCT00539214已完成不适用
Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,192
- 试验地点
- 1
- 主要终点
- Improvement of depressive symptoms (UPDRS item 3, HADS-D) compared to baseline in early and advanced Parkinsons's disease
研究概览
简要总结
- To compare the effect of pramipexole on depressive symptoms in early and advanced PD patients
- To evaluate the course of depressive symptoms measured with UPDRS Part I (mentation, behavior and mood) and with HADS-D under pramipexole treatment
- To investigate whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III)
详细描述
Study Design:
研究设计
- 研究类型
- Observational
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Improvement of depressive symptoms (UPDRS item 3, HADS-D) compared to baseline in early and advanced Parkinsons's disease
时间窗: 9-16 weeks
Change in sum scores of UPDRS Part III (motor examination) from baseline and UPDRS Part I (mentation, behavior and mood) from baseline
时间窗: 9-16 weeks
Change in HADS subscores (anxiety and depression) from baseline
时间窗: 9-16 weeks
次要结局
- Baseline pattern of patient rated symptom list (HADS)(9-16 weeks)
- Correlation of the change in UPDRS Part I and UPDRS Part III at the final visit(9-16 weeks)
- Frequency of adverse events(9-16 weeks)
研究者
研究点 (1)
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