Emotional Problem, Inflammation, Brain
Conditions
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.
Interventions
DIETARY_SUPPLEMENTbeverage containing mushroom-extracts
Subjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks.
Sponsors
National Taiwan University
National Science and Technology Council, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A triple-blind, randomized-controlled trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of subjective depressive symptoms | 8 weeks | Measured by Beck Depression Inventory-II |
| Change of objective depressive symptoms | 8 weeks | Measured by Hamilton Rating Scale for Depression |
| Change of somatic symptoms | 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 | 8 weeks | Measured as a stress-related biomarker |
Countries
Taiwan
Outcome results
None listed