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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-25

Study Completion Date

2020-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Depression in Parkinson's Disease

NCT01416818

Depression in Parkinson's Disease

UNKNOWN PHASE2

Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients

NCT01523301

Idiopathic Parkinson's Disease

COMPLETED PHASE4

Study of Antidepressants in Parkinson's Disease

NCT00086190

Parkinson Disease Depression

COMPLETED PHASE3

Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)

NCT01227265

Parkinson Disease Idiopathic Parkinson Disease Idiopathic Parkinson's Disease

COMPLETED PHASE3

Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease

NCT05709301

Parkinson Disease Mild Cognitive Impairment

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antidepressive Agents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wuling Powder Group

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

Group Type EXPERIMENTAL

Wuling Powder

Intervention Type DRUG

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

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wuling Powder

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

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No