Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation

NCT04002219 | Completed

• 1 other identifier: CMUH108-REC3-022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammation, Brain; Emotional Problem

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Active arm

EXPERIMENTAL

Subjects will receive treatment with active beverage containing the active ingredient

Dietary Supplement: beverage containing mushroom-extracts

Placebo arm

PLACEBO COMPARATOR

Subjects will receive treatment with placebo beverage not containing the active ingredient

Dietary Supplement: beverage containing mushroom-extracts

Interventions

beverage containing mushroom-extracts DIETARY_SUPPLEMENT

Subjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks.

Active arm; Placebo arm

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Science and Technology Council, Taiwan: lead
• National Taiwan University: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Encephalitis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Kuan-Pin Su, MD, PhD

  China Medical University, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A triple-blind, randomized-controlled trial

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 28, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: February 28, 2020
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

TW (1)