Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease
Primary Purpose
Antidepressive Agents
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Wuling Powder
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Antidepressive Agents focused on measuring Parkinson's disease, Depression, Wuling Powder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Wuling Powder Group
Placebo Group
Arm Description
Take Wuling Powder 3 times a day,3 pills each time for 12 weeks
Take placebo drug which cannot be distinguished from the experimental drug 3 times a day,3 pills each time for 12 weeks
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03195231
First Posted
June 20, 2017
Last Updated
June 20, 2017
Sponsor
Beijing Hospital
Collaborators
Tongji Hospital, Shanghai Tong Ren Hospital, The First Hospital of Hebei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03195231
Brief Title
Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2017 (Anticipated)
Primary Completion Date
December 15, 2019 (Anticipated)
Study Completion Date
January 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital
Collaborators
Tongji Hospital, Shanghai Tong Ren Hospital, The First Hospital of Hebei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antidepressive Agents
Keywords
Parkinson's disease, Depression, Wuling Powder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wuling Powder Group
Arm Type
Experimental
Arm Description
Take Wuling Powder 3 times a day,3 pills each time for 12 weeks
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Take placebo drug which cannot be distinguished from the experimental drug 3 times a day,3 pills each time for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Wuling Powder
Intervention Description
Patients of Wuling Group are instructed to take Wuling Powder 3 times a day and 3 pills each time for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients of Placebo Group are instructed to take placebo drug 3 times a day and 3 pills each time for 12 weeks.
Primary Outcome Measure Information:
Title
the change of depression from baseline to 12 weeks
Description
the change of depression from baseline to 12 weeks,as assessed with the use of HAMD(Hamilton Depression Scale)
Time Frame
12 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wang
Phone
+8613661174001
Email
wangxinannie@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Su
Organizational Affiliation
Beijing Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease
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