Treatment of Depression in Parkinson's Disease

August 11, 2011 updated by: Xuanwu Hospital, Beijing

A Randomized, Double-Blind, Placebo-Controlled Study of "Xiaoyao Pill" Treatment of Depression in Patients With Parkinson's Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Piu Chan, MD,PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Depression Scale
Time Frame: 12 weeks
Change of Hamilton Depression Scale score on week 12 from baseline.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the responder rate (defined as score reduction of HAMD-17>=50%)
Time Frame: 12 weeks
12 weeks
the Geriatric Depression Scale
Time Frame: 12 weeks
GDS-30
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Principal Investigator: Piu Chan, MD. PhD., Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

August 11, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (Estimate)

August 15, 2011

Study Record Updates

Last Update Posted (Estimate)

August 15, 2011

Last Update Submitted That Met QC Criteria

August 11, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008XYRCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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