Treatment of Depression in Parkinson's Disease

NCT ID: NCT01416818

Last Updated: 2011-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Depression in Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group 1

Group Type EXPERIMENTAL

Xiaoyao Pill

Intervention Type DRUG

herb extracts,were received two times a day for 12 weeks without dose changing.

group 2

Group Type ACTIVE_COMPARATOR

Bupleurum+Ginkgo

Intervention Type DRUG

herb extracts, were received two times a day for 12 weeks without dose changing.

group 3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing.

Interventions

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Xiaoyao Pill

herb extracts,were received two times a day for 12 weeks without dose changing.

Intervention Type DRUG

Bupleurum+Ginkgo

herb extracts, were received two times a day for 12 weeks without dose changing.

Intervention Type DRUG

placebo

The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Xuanwu Hospital

Principal Investigators

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Piu Chan, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

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Xuanwu Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jinglin Zhang, MD, PhD.

Role: CONTACT

+86-10-83198677

Facility Contacts

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Piu Chan, M.D., Ph.D.

Role: primary

+86-10-83198677

Role: backup

Other Identifiers

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2008XYRCT

Identifier Type: -

Identifier Source: org_study_id

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