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Treatment of Depression in Parkinson's Disease

This study is currently recruiting participants.
Verified August 2011 by Xuanwu Hospital, Beijing
Sponsor:
Information provided by:
Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT01416818
First received: August 11, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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 Intervention Phase
Depression in Parkinson's Disease
 Drug: Xiaoyao Pill
Drug: Bupleurum+Ginkgo
Drug: placebo
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xuanwu Hospital, Beijing:

Primary Outcome Measures:
  • Hamilton Depression Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change of Hamilton Depression Scale score on week 12 from baseline.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Piu Chan, MD, PhD., Xuanwu Hospital
ClinicalTrials.gov Identifier: NCT01416818     History of Changes
Other Study ID Numbers: 2008XYRCT
Study First Received: August 11, 2011
Last Updated: August 11, 2011
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013