A Study on Depression Related Indicators of Healthy Wome
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0002704
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 50
1) Women aged 20 to 65 years
2) The Korean Hamilton Depression Rating Scale score is less than 7
3) Those who can make sufficient communication and questionnaire
4) Decide on voluntary participation and sign the written agreement
1) People with a medical condition that may affect the degree of depression (eg, myocardial infarction, brain tumor, multiple sclerosis, hyperthyroidism, hyperparathyroidism, Addison's disease, Cushing's disease, rheumatoid arthritis, Vascular disease, epilepsy, etc.)
2) Those who have undergone medical surgery or treatment within 1 month of the start of clinical research
3) Those who have had acute and chronic infectious diseases for the last 2 weeks
4) Those who had excessive diet control for disease-related or weight control purposes within one week of the start of clinical studies
5) Those who are taking periodical medicines by internal medicine, surgery, psychiatric diagnosis at the time of starting the clinical study, and those who are thought to be able to influence the autonomic nervous system and depressive symptom manifestations (eg anxiolytics, antidepressants, L-dopa, Digitalis, bromide, cyclosporin, disulfiram, isoniazid, yohimbine, etc.)
6) Those who have been diagnosed with medical or psychiatric disorders and have not been informed about clinical symptoms or biochemical indicators
7) Those with chronic diseases that are not well controlled by appropriate treatment (chronic active hepatitis, hypertension, diabetes, etc.)
8) Those who are treated with liver cancer or liver cirrhosis, chronic renal failure, congestive heart failure, etc.
9) Those who are pregnant or are pregnant or are lactating
10) AST or ALT exceeds 2 times the upper limit of the reference range, or Total Bilirubin exceeds 2 times the upper limit of the reference range
11) Patients with renal impairment (Cockcroft-Gault-type creatinine clearance less than 50 mL / min
12) Alcohol or other substance Abuse / Dependence or history
13) Those who participated in other clinical studies with intervention within one month before the start of the study
14) Those who do not understand the consent because of mental retardation and intellectual problems, or are unable to continue the research
15) Those who have communication difficulties that are difficult to follow the directions of the researcher
16) Any other person who is considered to be ineligible to take the test
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Korean Hamilton Depression Rating Scale(K-HDRS);The Korean version of the Beck Depression Inventory(BDI-K);Pattern identifications tool for Depression;Korean Symptom Checklist-95 (KSCL-95);Insomnia Severity Index (ISI);State-Trait Anxiety Inventory;EuroQol-5 dimension (EQ-5D);Revised "Neuroticism, Extraversion, Openness to experience" Personality Inventory(NEO-PI-R);Emotional Stimulus Test;Brain-derived neurotrophic factor (BDNF);Inflammatory cytokines and tumor necrosis factor (IL-1ß, IL-2, IL-4, IL-6, IL-10, TNF-a, IFN-?, TGF-ß1);Depression-related genetic polymorphism & Epigenetic test (SLC6A4, SLC6A3, SLC1A1, GAD1, NR2A, NRG1, TPH2, GRM7, OXTR, AVPR1A, MGLUR5, COMT, BDNF, IL6, IL1beta);microbiome;Diet report
- Secondary Outcome Measures
Name Time Method Adverse reaction