Treatment of Depression in Parkinson's Disease

Phase 2

• Conditions: Depression in Parkinson's Disease
• Interventions: Drug: placebo; Drug: Bupleurum+Ginkgo; Drug: Xiaoyao Pill

• Registration Number: NCT01416818
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-05
• Status Verified: 2011-08
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-11
• Last Update Submitted: 2011-08-11
• Study First Posted: 2011-08-15
• Last Update Posted: 2011-08-15
• Primary Completion: 2011-10
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 3	placebo	-
group 2	Bupleurum+Ginkgo	-
group 1	Xiaoyao Pill	-

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale	12 weeks	Change of Hamilton Depression Scale score on week 12 from baseline.

Secondary Outcome Measures

Name	Time	Method
the Geriatric Depression Scale	12 weeks	GDS-30
the responder rate (defined as score reduction of HAMD-17>=50%)	12 weeks

Trial Locations

Locations (1)

Xuanwu Hospital; 🇨🇳 Beijing, China