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Treatment of Depression in Parkinson's Disease

Primary Purpose

Depression in Parkinson's Disease

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Xiaoyao Pill
Bupleurum+Ginkgo
placebo
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression in Parkinson's Disease focused on measuring Depression;, Parkinson's disease;, antidepressant

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xuanwu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

group 1

group 2

group 3

Arm Description

Outcomes

Primary Outcome Measures

Hamilton Depression Scale
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%)
the Geriatric Depression Scale
GDS-30

Full Information

First Posted
August 11, 2011
Last Updated
August 11, 2011
Sponsor
Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT01416818
Brief Title
Treatment of Depression in Parkinson's Disease
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of "Xiaoyao Pill" Treatment of Depression in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Xuanwu Hospital, Beijing

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Parkinson's Disease
Keywords
Depression;, Parkinson's disease;, antidepressant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Experimental
Arm Title
group 2
Arm Type
Active Comparator
Arm Title
group 3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Xiaoyao Pill
Intervention Description
herb extracts,were received two times a day for 12 weeks without dose changing.
Intervention Type
Drug
Intervention Name(s)
Bupleurum+Ginkgo
Intervention Description
herb extracts, were received two times a day for 12 weeks without dose changing.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing.
Primary Outcome Measure Information:
Title
Hamilton Depression Scale
Description
Change of Hamilton Depression Scale score on week 12 from baseline.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
the responder rate (defined as score reduction of HAMD-17>=50%)
Time Frame
12 weeks
Title
the Geriatric Depression Scale
Description
GDS-30
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinglin Zhang, MD, PhD.
Phone
+86-10-83198677
Email
littlenumskull@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piu Chan, MD. PhD.
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piu Chan, M.D., Ph.D.
Phone
+86-10-83198677
Email
pbchan@hotmail.com
Email
pbchan90@gmail.com
First Name & Middle Initial & Last Name & Degree
Piu Chan, MD,PhD.

12. IPD Sharing Statement

Learn more about this trial

Treatment of Depression in Parkinson's Disease

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