Randomized Controlled Study to Evaluate Safety and Efficacy of Banhahubaktang in Patients with Depressio

Not Applicable

• Conditions: Mental and behavioural disorders

• Registration Number: KCT0007272
• Lead Sponsor: Kyung Hee University Oriental Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. K-HDRS score of 18 or higher
2. Men and women between the ages of 19 and 65
3. Volunteered to participate and signed the consent form
4. Diagnosed with major depressive disorder of DSM-V

Exclusion Criteria

1. At risk of suicide
2. K-HDRS score of 27 or higher
3. Diagnosed with major depressive disorder who require hospitalization
4. Patients who have received electrotherapy, vagus nerve stimulation, deep brain stimulation, phototherapy, transcranial magnetic stimulation, or psychotherapy within the past 3 months
5. Panic disorder, obsessive compulsive disorder, post-traumatic stress disorder, antisocial personality disorder, borderline personality disorder, theatrical personality disorder, or other severe personality disorder (paranoid, schizoid, narcissistic, avoidant, dependent personality disorder, etc.)
6. Manic episodes, hypomanic episodes, or mixed episodes
7. Abuse/dependence on alcohol or other substances
8. Use of substances or drugs that can affect the severity of depression (eg, anti-anxiety drugs, antidepressants, antipsychotics, corticosteroids, female hormones, L-dopa, Digitalis, bromide, cyclosporin, disulfiram, isoniazid, yohimbine, etc. that are being administered alone or as multiple (combination therapy) (except when 4 weeks have elapsed since the last dose of the drug at the time of screening)
9. Use of a thrombolytic or anticoagulant
10. Medical conditions that may affect the severity of depressive symptoms (e.g., myocardial infarction, arrhythmia, brain tumor, multiple sclerosis, pancreatic disease, hypothyroidism/hyperthyroidism, hyperparathyroidism, Addison's disease, Cushing's disease, rheumatism) Arthritis, cancer, cerebrovascular disease, dementia, epilepsy, etc.)
11. Chronic diseases that are not well controlled despite appropriate treatment (chronic active hepatitis, high blood pressure, diabetes, etc.), Poorly controlled hypertension refers to a condition in which blood pressure is not controlled below 140/90 mmHg even after three or more antihypertensive drugs have been administered in sufficient dose and combination of appropriate drugs including diuretics. It refers to a state in which HbA1c = 9.0% is maintained despite the combination of and administration at a sufficient dose.
12. Being treated for liver cancer, cirrhosis, chronic renal failure, etc. or are being treated for congestive heart failure classified as NYHA Class III-IV
13. Hepatic and renal dysfunction (at screening, ALT, AST, ALP = 2 times the upper limit of normal or creatinine > 2.0 mg/dL)
14. Genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
15. A disease that may affect drug absorption or have digestive problems after related surgery
16. Enrollment in another clinical trial within 1 month before the start of the study
17. Hypersensitivity or allergy to research-related drugs
18. Use of herbal medicines or herbal preparations other than this investigational drug
19. Those who do not understand the consent form or have difficulty in continuing research due to mental retardation or intellectual problems
20. Pregnant or lactating women
21. Those who are pregnant and do not agree to the accepted contraceptive methods (dual contraception*, intrauterine contraceptive device and spermicide) during the clinical trial period
*Double contraception refers to the case of using hepatic contraception (condoms, diaphragm, etc.) together with other contraceptive methods (sterilization, intrauterine contraceptive device, contraceptive cream, jelly or foam, etc.).
22. In case the investigator is determine inappropriate to participate in the clinical trial due to other reasons

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Korean Hamilton Depression Rating Scale (K-HDRS)

Secondary Outcome Measures

Name	Time	Method
Korean Hamilton Depression Rating Scale (K-HDRS);Korean Hamilton Depression Rating Scale (K-HDRS) improvement rate (proportion of subjects who showed improvement in total score of 50% or more);Korean Hamilton Depression Rating Scale (K-HDRS) remission rate (proportion of subjects whose total score improved to 7 or less);Korean-Beck Depression Inventory-II (K-BDI-II);Korean Symptom Check List 95 (KSCL-95);Insomnia Severity Index (ISI);Korean State-Trait Anxiety Inventory (STAI-K);Instrument on Pattern Identifications for Depression;EuroQol-5 dimension (EQ-5D)