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

Sponsor

Beijing Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03195231

Collaborator

Tongji Hospital (Other), Shanghai Tong Ren Hospital (Other), The First Hospital of Hebei Medical University (Other)

120

Enrollment

Arms

30.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Antidepressive Agents	Drug: Wuling Powder Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 25, 2017

Anticipated Primary Completion Date :

Dec 15, 2019

Anticipated Study Completion Date :

Jan 15, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Wuling Powder Group

Take Wuling Powder 3 times a day，3 pills each time for 12 weeks

Drug: Wuling Powder

Patients of Wuling Group are instructed to take Wuling Powder 3 times a day and 3 pills each time for 12 weeks.

Placebo Comparator: Placebo Group

Take placebo drug which cannot be distinguished from the experimental drug 3 times a day，3 pills each time for 12 weeks

Drug: Placebo

Patients of Placebo Group are instructed to take placebo drug 3 times a day and 3 pills each time for 12 weeks.

Outcome Measures

Primary Outcome Measures

the change of depression from baseline to 12 weeks [12 weeks after treatment]
the change of depression from baseline to 12 weeks,as assessed with the use of HAMD（Hamilton Depression Scale）

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Beijing Hospital
Tongji Hospital
Shanghai Tong Ren Hospital
The First Hospital of Hebei Medical University

Investigators

Principal Investigator: Wen Su, Beijing Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wen Su, Clinical professor and Principal investigator, Beijing Hospital

ClinicalTrials.gov Identifier:

NCT03195231

Other Study ID Numbers:

121-2016009

First Posted:

Jun 22, 2017

Last Update Posted:

Jun 22, 2017

Last Verified:

Jun 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wen Su, Clinical professor and Principal investigator, Beijing Hospital

Parkinson's disease

Depression

Wuling Powder

Additional relevant MeSH terms:

Parkinson Disease

Depression

Study Results

No Results Posted as of Jun 22, 2017