Treatment of Depression in Parkinson's Disease
Recruitment status was Recruiting
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.
Depression in Parkinson's Disease
Drug: Xiaoyao Pill
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study of "Xiaoyao Pill" Treatment of Depression in Patients With Parkinson's Disease|
- Hamilton Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Change of Hamilton Depression Scale score on week 12 from baseline.
- the responder rate (defined as score reduction of HAMD-17>=50%) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- the Geriatric Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]GDS-30
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Experimental: group 1||
Drug: Xiaoyao Pill
herb extracts,were received two times a day for 12 weeks without dose changing.
|Active Comparator: group 2||
herb extracts, were received two times a day for 12 weeks without dose changing.
|Placebo Comparator: group 3||
The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416818
|Contact: Jinglin Zhang, MD, PhD.||+firstname.lastname@example.org|
|Beijing, China, 100053|
|Contact: Piu Chan, M.D., Ph.D. +86-10-83198677 email@example.com|
|Principal Investigator: Piu Chan, MD,PhD.|
|Principal Investigator:||Piu Chan, MD. PhD.||Xuanwu Hospital, Beijing|