Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2019

Interventions

  • Dietary Supplement: beverage containing mushroom-extracts
    • Subjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks.

Arms, Groups and Cohorts

  • Experimental: Active arm
    • Subjects will receive treatment with active beverage containing the active ingredient
  • Placebo Comparator: Placebo arm
    • Subjects will receive treatment with placebo beverage not containing the active ingredient

Clinical Trial Outcome Measures

Primary Measures

  • Change of subjective depressive symptoms
    • Time Frame: 8 weeks
    • Measured by Beck Depression Inventory-II
  • Change of objective depressive symptoms
    • Time Frame: 8 weeks
    • Measured by Hamilton Rating Scale for Depression
  • Change of somatic symptoms
    • Time Frame: 8 weeks
    • 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.
  • Cortisol level
    • Time Frame: 8 weeks
    • Measured as a stress-related biomarker

Participating in This Clinical Trial

Inclusion Criteria

1. 21 -items Hamilton Rating Scale for Depression scores 8-17 points upon interview 2. At least 2 weeks not taking antidepressants, antipsychotics or antiepileptics. 3. Understand the whole process of the study and had signed the informed consent form Exclusion Criteria:

1. 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. 2. Currently taking antidepressants or other medication that may impact the study. 3. Expected to be non-adherent. 4. Without sufficient data to confirm safety. 5. Pregnant woman 6. Allergic to fungal products. 7. Currently taking MAO-inhibitors

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Science Council, Taiwan
  • Collaborator
    • National Taiwan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kuan-Pin, Principal Investigator – National Science Council, Taiwan
  • Overall Official(s)
    • Kuan-Pin Su, MD, PhD, Study Director, China Medical University, China

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