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Treatment of Depression in Parkinson's Disease

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Xuanwu Hospital, Beijing

关键词

抽象

The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-"Xiaoyao Pill" (Herb extracts)on depression, compared to placebo and "Bupleurum+Ginkgo" in patients with Parkinson's disease.

描述

Depression as the most common non-motor comorbidity of Parkinson's disease (PD), have a negative impact on disability and quality of life.

Traditional Chinese Medicine has shown effects on several depression. It is not known if TCM also is effective for depression in PD. This study is to investigate "Xiaoyao Pill", an antidepressant in TCM, on depression in PD.

A total of 60 patients with depression in PD will be randomized to each of the three arms.

日期

最后验证: 07/31/2011
首次提交: 08/10/2011
提交的预估入学人数: 08/10/2011
首次发布: 08/14/2011
上次提交的更新: 08/10/2011
最近更新发布: 08/14/2011
实际学习开始日期: 04/30/2008
预计主要完成日期: 09/30/2011
预计完成日期: 11/30/2011

状况或疾病

Depression in Parkinson's Disease

干预/治疗

Drug: group 1

Drug: group 2

Drug: group 3

相 2

手臂组

干预/治疗
Experimental: group 1
Drug: group 1
herb extracts,were received two times a day for 12 weeks without dose changing.
Active Comparator: group 2
Drug: group 2
herb extracts, were received two times a day for 12 weeks without dose changing.
Placebo Comparator: group 3
Drug: group 3
The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing.

资格标准

有资格学习的年龄 30 Years 至 30 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

- Parkinson's disease without dementia

- Depression

- Males or females

- Willing and able to give informed consent

Exclusion Criteria:

- cognitive dysfunction

- other serious diseases

结果

主要结果指标

1. Hamilton Depression Scale [12 weeks]

Change of Hamilton Depression Scale score on week 12 from baseline.

次要成果指标

1. the responder rate (defined as score reduction of HAMD-17>=50%) [12 weeks]

2. the Geriatric Depression Scale [12 weeks]

GDS-30

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