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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
Sponsor:
Information provided by:
Xuanwu Hospital, Beijing

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression in Parkinson's Disease Drug: Xiaoyao Pill Drug: Bupleurum+Ginkgo Drug: placebo Phase 2

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2008
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: group 1 Drug: Xiaoyao Pill
herb extracts,were received two times a day for 12 weeks without dose changing.
Active Comparator: group 2 Drug: Bupleurum+Ginkgo
herb extracts, were received two times a day for 12 weeks without dose changing.
Placebo Comparator: group 3 Drug: placebo
The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing.



Primary Outcome Measures :
  1. Hamilton Depression Scale [ Time Frame: 12 weeks ]
    Change of Hamilton Depression Scale score on week 12 from baseline.


Secondary Outcome Measures :
  1. the responder rate (defined as score reduction of HAMD-17>=50%) [ Time Frame: 12 weeks ]
  2. the Geriatric Depression Scale [ Time Frame: 12 weeks ]
    GDS-30



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Jinglin Zhang, MD, PhD. +86-10-83198677 littlenumskull@hotmail.com

Locations
China
Xuanwu Hospital Recruiting
Beijing, China, 100053
Contact: Piu Chan, M.D., Ph.D.    +86-10-83198677    pbchan@hotmail.com   
Contact       pbchan90@gmail.com   
Principal Investigator: Piu Chan, MD,PhD.         
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
Principal Investigator: Piu Chan, MD. PhD. Xuanwu Hospital, Beijing

Responsible Party: Piu Chan, MD, PhD., Xuanwu Hospital
ClinicalTrials.gov Identifier: NCT01416818     History of Changes
Other Study ID Numbers: 2008XYRCT
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: August 15, 2011
Last Verified: August 2011

Keywords provided by Xuanwu Hospital, Beijing:
Depression;
Parkinson's disease;
antidepressant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Parkinson Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases