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

Antidepressive Agents Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03195231
• Other study ID #: 121-2016009
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 20, 2017
• Last updated: June 20, 2017
• Start date: June 25, 2017
• Est. completion date: January 15, 2020

Study information

• Verified date: June 2017
• Source: Beijing Hospital
• Contact: Xin Wang
• Phone: +8613661174001
• Email: wangxinannie[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 15, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson`s disease according to the 2015 MDS(Movement Disorder Society)-PD criterion

2. Hoehn-Yahr stage: 1-3

3. Under steady therapy of antiparkinsonian drugs for at least 28 days

4. HAMD=13

5. MMSE(Mini-Mental State Examination)=24

6. Neither use antidepressant drugs nor antipsychotic drugs within 4 weeks

7. Signed informed consent

Exclusion Criteria:

1. Have other psychotic symptoms

2. Suicide ideation or behavior

3. Severe cognitive impairment,chronic organs failure,malignant tumors

4. 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

5. Pregnancy or lactation period

6. Participant in other trials or have taken other experimental drugs within 90 days

7. Allergic to fungal food or fungal drugs

Related Conditions & MeSH terms

• Antidepressive Agents
• Depression
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Beijing Hospital	Shanghai Tong Ren Hospital, The First Hospital of Hebei Medical University, Tongji Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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