Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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Depression is one of the most important nonmotor features of idiopathic PD（Parkinson's disease ）which may not just interfere with the motor symptoms of PD but can also cause immense personal suffering as well as decreased quality of life with increased disability and caregiver burden. However,there is little hard evidence to guide clinical treatment. Although some newer dopamine agonists also have antidepressive effect, the use of tricyclic or nontricyclic antidepressants is frequently required.However, the side-effects of these agents may also worsen some preexisting nonmotor problems in PD. Wuling powder is a Chinese medicine which is made by cultivating Xylariasp mycelium using submerged fermentation technology. Xylariasp is the fungus sclerotia which grow in termite nests. Wuling powder is mainly used to soothe nerves and anti-insomnia in clinical. The antidepressant effect of Wuling powder has been confirmed in clinical, but not in the patients of Parkinson's disease. Therefore, the investigators design a randomized, double-blind, placebo-controlled study to evaluate the antidepressant effect of Wuling powder in PD patients and its underlying mechanism.

Official Title
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Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial.

Conditions
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Antidepressive Agents

Intervention / Treatment
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* Drug: Wuling Powder
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of idiopathic Parkinson's disease according to the 2015 MDS（Movement Disorder Society）-PD criterion Hoehn-Yahr stage: 1-3 Under steady therapy of antiparkinsonian drugs for at least 28 days HAMD≥13 MMSE（Mini-Mental State Examination）≥24 Neither use antidepressant drugs nor antipsychotic drugs within 4 weeks Signed informed consent Exclusion Criteria: Have other psychotic symptoms Suicide ideation or behavior Severe cognitive impairment，chronic organs failure，malignant tumors Glutamic-pyruvic transaminase or glutamic oxalacetic transaminase≥1.5 times of the high normal range or white blood cell<4*10^9/L or serum creatinine>84umol/L Pregnancy or lactation period Participant in other trials or have taken other experimental drugs within 90 days Allergic to fungal food or fungal drugs

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wuling Powder Group<br>Take Wuling Powder 3 times a day，3 pills each time for 12 weeks | Drug: Wuling Powder<br>* Patients of Wuling Group are instructed to take Wuling Powder 3 times a day and 3 pills each time for 12 weeks.<br>|
| Placebo Comparator: Placebo Group<br>Take placebo drug which cannot be distinguished from the experimental drug 3 times a day，3 pills each time for 12 weeks | Drug: Placebo<br>* Patients of Placebo Group are instructed to take placebo drug 3 times a day and 3 pills each time for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of depression from baseline to 12 weeks | the change of depression from baseline to 12 weeks,as assessed with the use of HAMD（Hamilton Depression Scale） | 12 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Depression, Wuling Powder