Treatment of Depression in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01416818|
Recruitment Status : Unknown
Verified August 2011 by Xuanwu Hospital, Beijing.
Recruitment status was: Recruiting
First Posted : August 15, 2011
Last Update Posted : August 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Depression in Parkinson's Disease||Drug: Xiaoyao Pill Drug: Bupleurum+Ginkgo Drug: placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study of "Xiaoyao Pill" Treatment of Depression in Patients With Parkinson's Disease|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||December 2011|
|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.
- Hamilton Depression Scale [ Time Frame: 12 weeks ]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 ]
- the Geriatric Depression Scale [ Time Frame: 12 weeks ]GDS-30
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416818
|Contact: Jinglin Zhang, MD, PhD.||+email@example.com|
|Beijing, China, 100053|
|Contact: Piu Chan, M.D., Ph.D. +86-10-83198677 firstname.lastname@example.org|
|Principal Investigator: Piu Chan, MD,PhD.|
|Principal Investigator:||Piu Chan, MD. PhD.||Xuanwu Hospital, Beijing|