Treatment of Depression in Parkinson's Disease

Depression in Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01416818
• Other study ID #: 2008XYRCT
• Status: Unknown status
• Phase: Phase 2
• First received: August 11, 2011
• Last updated: August 11, 2011
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2011
• Source: Xuanwu Hospital, Beijing
• Contact: Jinglin Zhang, MD, PhD.
• Phone: +86-10-83198677
• Email: littlenumskull[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression in Parkinson's Disease
• Depressive Disorder
• Parkinson Disease

Intervention

Drug:
• Xiaoyao Pill
herb extracts,were received two times a day for 12 weeks without dose changing.
• Bupleurum+Ginkgo
herb extracts, were received two times a day for 12 weeks without dose changing.
• placebo
The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing.

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale	Change of Hamilton Depression Scale score on week 12 from baseline.	12 weeks
Secondary	the responder rate (defined as score reduction of HAMD-17>=50%)		12 weeks
Secondary	the Geriatric Depression Scale	GDS-30	12 weeks