Treatment of Depression in Parkinson's Disease

Capital Medical University

Status and phase: Unknown; Phase 2

Conditions: Depression in Parkinson's Disease

Treatments: Drug: Xiaoyao Pill; Drug: Bupleurum+Ginkgo; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01416818

2008XYRCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

group 1

Experimental group

Treatment:

Drug: Xiaoyao Pill

group 2

Active Comparator group

Treatment:

Drug: Bupleurum+Ginkgo

group 3

Placebo Comparator group

Treatment:

Drug: placebo