Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation

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 Overview

• Status: Completed
• Conditions: Emotional Problem; Inflammation, Brain
• Intervention / Treatment: Dietary supplement: beverage containing mushroom-extracts

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Science Council, Taiwan
• Collaborators: National Taiwan University
• Investigators: Study Director: Kuan-Pin Su, MD, PhD, China Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalitis; Inflammation
• Other Study ID Numbers: CMUH108-REC3-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The study has not yet fully discuss the plan for IPD opening.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No