Treatment of Depression in Parkinson's Disease

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01416818

Enrollment

Registered

2011-08-15

Start date

2008-05-31

Completion date

2011-12-31

Last updated

2011-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression in Parkinson's Disease

Keywords

Depression;, Parkinson's disease;, antidepressant

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.

Interventions

DRUGXiaoyao Pill

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

DRUGBupleurum+Ginkgo

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactJinglin Zhang, MD, PhD.

littlenumskull@hotmail.com+86-10-83198677

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026