Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation

Study Overview
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Brief Summary
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Major Depression Disorder is one of the most common psychiatric disease and has affecting approximately 350 million people in the world. According to World Health Organization's report, it may be the first burden of disease in 2030. Due to the high morbidity and low acceptance in the treatment, it is necessary to find some nature compounds to prevent the disease. Cordyceps militaris, one of the most treasure Chinese herbs in Asia, contains many kinds of component such as cordycepin, polysaccharide, mannitol. In winter, it appears as an worm in the soil, afterwards, it grows out of the soil and convert into grass in summer. A previous study has demonstrated that Cordyceps militaris has anti-depressive effect in mouse tail suspension test, and in this study we will explore its effect in human subjects.

Official Title
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Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation

Conditions
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Inflammation, Brain, Emotional Problem

Intervention / Treatment
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* Dietary Supplement: beverage containing mushroom-extracts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 -items Hamilton Rating Scale for Depression scores 8-17 points upon interview At least 2 weeks not taking antidepressants, antipsychotics or antiepileptics. Understand the whole process of the study and had signed the informed consent form Exclusion Criteria: Had been diagnosed with severe mental disorder, schizophrenia, bipolar disorder, personality disorder, substance use disorder or alcohol use disorder, or other severe physical illness that is not expected to survive during the intervention period. Currently taking antidepressants or other medication that may impact the study. Expected to be non-adherent. Without sufficient data to confirm safety. Pregnant woman Allergic to fungal products. Currently taking MAO-inhibitors

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A triple-blind, randomized-controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active arm<br>Subjects will receive treatment with active beverage containing the active ingredient | Dietary Supplement: beverage containing mushroom-extracts<br>* Subjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks.<br>|
| Placebo Comparator: Placebo arm<br>Subjects will receive treatment with placebo beverage not containing the active ingredient | Dietary Supplement: beverage containing mushroom-extracts<br>* Subjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of subjective depressive symptoms | Measured by Beck Depression Inventory-II | 8 weeks | 
| Change of objective depressive symptoms | Measured by Hamilton Rating Scale for Depression | 8 weeks | 
| Change of somatic symptoms | Measured by Neurotoxicity Rating Scale, a 39-item self-report scale to evaluate the somatic symptoms such as anorexia, fatigue and pain; higher scores indicate higher severity. | 8 weeks | 
| Cortisol level | Measured as a stress-related biomarker | 8 weeks |