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

NCT03195231 | Unknown Phase 4

• 1 other identifier: 121-2016009
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Antidepressive Agents

Keywords

Parkinson's disease; Depression; Wuling Powder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Wuling Powder Group

EXPERIMENTAL

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

Drug: Wuling Powder

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Wuling Powder DRUG

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

Wuling Powder Group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Hospital: lead
• Tongji Hospital: collaborator
• Shanghai Tong Ren Hospital: collaborator
• The First Hospital of Hebei Medical University: collaborator

MeSH Terms

Conditions

Parkinson Disease; Depression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Study Officials

• Wen Su

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Wang

CONTACT

+8613661174001; wangxinannie@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor and Principal investigator

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: June 25, 2017
• Primary Completion: December 15, 2019
• Study Completion: January 15, 2020
• Last Updated: June 22, 2017

Record last verified: 2017-06