Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation

Emotional Problem Clinical Trial

Official title:

Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002219
• Other study ID #: CMUH108-REC3-022
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: October 2022
• Source: National Science Council, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 28, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Emotional Problem
• Encephalitis
• Inflammation
• Inflammation, Brain

Intervention

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

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
National Science Council, Taiwan	National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of subjective depressive symptoms	Measured by Beck Depression Inventory-II	8 weeks
Primary	Change of objective depressive symptoms	Measured by Hamilton Rating Scale for Depression	8 weeks
Primary	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
Primary	Cortisol level	Measured as a stress-related biomarker	8 weeks