A Clinical Trial to Evaluate Safety and Efficacy of BTS Granule in Depressive Disorder

Not Applicable

Recruiting

• Conditions: Mental and behavioural disorders

• Registration Number: KCT0007571
• Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1. Men and women aged 19 to 65
2. Participant diagnosed with major depressive disorder in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5)
3. Participant with a K-HDRS(Korean Version of the Hamilton Depression Rating Scale) score of 18 or higher
4. Participant with a BMI (Body Mass Index) of 18.5 or higher
5. Participant who voluntarily decide to participate and sign the agreement

Exclusion Criteria

1. Participant with a risk of suicide
2. Participant with major depressive disorder who need hospitalization treatment
3. Participant who received electroconvulsive therapy (ECT), vagal nerve stimulation (VNS), deep brain stimulation (DBS), light therapy, or transcranial magnetic stimulation (TMS) within three months
4. Participant who are diagnosed and being treated as a panic disorder, obsessive disorder, post-traumatic stress disorder, or personality disorder
5. Participant with a history of manic, schizophrenic, or mixed episode
6. Participant with a current or lifetime alcohol or other substance abuse/dependence
7. Participant who are taking medicines or substances that may affect the degree of depression (eg. anxiolytics, antidepressants, antipsychotics, corticosteroids, female hormones, L-dopa, Digitalis, bromide, cyclosporin, disulfiram, isoniazid, yohimbine) within 4 weeks
8. Participant who have experienced defecations more than 3 times a day within 7 days and loose stool, or who are taking other laxatives
9. Participant with symptoms of abdominal pain, vomiting, or loss of appetite due to digestive disorders
10. Participant with a medical condition that may affect the degree of depression (eg. myocardial infarction, brain tumor, multiple sclerosis, pancreatic disease, hypo/hyperthyroidism, hyperparathyroidism, Addison's disease, Cushing's disease, rheumatoid arthritis, Cancer, cerebrovascular disease, dementia, epilepsy, etc.)
11. Participant with chronic illnesses that are not well controlled with proper treatment (chronic active hepatitis, hypertension, diabetes, etc.)
12. Participant who are being treated for liver cancer, liver cirrhosis, chronic kidney failure, or who are being treated with congestive heart failure classified as NYHA Class III-IV
13. Participant with liver dysfunction or renal impairment (ALT, AST, ALP = twice the normal upper limit or creatinine > 2.0 mg/dL at screening)
14. Participant with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
15. Participant who has a disease that may affect the absorption of the drug or who has a digestive disorder after surgery
16. Participant who participated in the other clinical trials within 3 month
17. Participant with hypersensitivity reactions and allergies to investigational product
18. Participant who are taking other herbal medicines
19. Participant who are unable to understand the consent form due to mental retardation or intellectual problems
20. Pregnant or lactating women
21. Participant who are likely to be pregnant and who do not agree to the approved methods of contraception (double contraception, intrauterine contraceptive, and spermicide) during the trial
22. Participant who are determined to be unsuitable by the investigator

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Korean Version of the Hamilton Depression Rating Scale (K-HDRS) - Change in total score

Secondary Outcome Measures

Name	Time	Method
Korean Version of the Hamilton Depression Rating Scale (K-HDRS) - Change in total score;Korean Version of the Hamilton Depression Rating Scale (K-HDRS) - Percentage of participants whose total score improved by more than 50%;Korean Version of the Hamilton Depression Rating Scale (K-HDRS) - Percentage of participants whose total score improved by less than 7 points;The Korean version of the Beck Depression Inventory-? (K-BDI-?);Korean Symptom Check List 95 (KSCL-95);Korean version of Insomnia Severity Index (ISI-K);State-Trait Anxiety Inventory- form Korean YZ (STAI-KYZ);State-Trait Anger Expression Inventory- Korean version (STAXI-K);Pattern Identifications Tool for Depression (PIT-D);3-level version of EuroQol-5 Dimension (EQ-5D-3L);Body Mass Index (BMI)