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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04002219
Other study ID # CMUH108-REC3-022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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