Clinical trial NCT03195231: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Antidepressive Agents
Keywords: Parkinson's disease
Depression
Wuling Powder
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Tongji Hospital
name: Shanghai Tong Ren Hospital
name: The First Hospital of Hebei Medical University
First posted: 2017-06-22
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: the change of depression from baseline to 12 weeks
timeFrame: 12 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Hospital
name: Wen Su
role: PRINCIPAL_INVESTIGATOR
References: