Mild to moderate depression Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
Patients are randomised to receive
1. PM011 (extract of nelumbinis semen [lotus seed]), low dose 1200mg/day (400mg pill x 3 times daily)
2. PM011, moderate dose 2400 mg/day (800 mg pill x 3 times dail
Sponsors
Purimed (South Korea)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient aged 18 to 65 male or female 2. Patient diagnosed as major depressive disorder by DSM-?W, had major depressive episode during last 30 days (before screening day) 3. 17-item Hamilton Rating Scale for Depression (HAM-D) scored 18 to 25 4. Patient given written informed consent form 5. Patient given written informed consent form of genetic study
Exclusion criteria
Exclusion criteria: 1. Woman who is pregnant, breast-feeding or not using appropriate contraception 2. Patient who has risk committing suicide, above 2 on the HAM-D suicide item (item #3) 3. Patient who has neurologic or psychiatric disorder except depression (schizophrenia, bipolar disorder, epilepsy, drug abuse, alcohol abuse, panic disorder or agitation that needs treatment etc) 4. Seriously irritable patient 5. Patient who has clinically significant liver disease or liver enzyme levels elevated to at least twice the upper normal limit 6. Patient who has chronic renal failure or over 1.5 folds blood creatinine level compared with the upper normal limit 7. Patient whose elevated laboratory test level that cause affective disorder (ex. thyroid disorder) 8. Patient who is not responder of anti-depressant or has history of non-response 9. Patient that had participated in another clinical trial in 1 month before screening day 10. Patient who is hypersensitive or has allergy about intervention 11. Patient who has digestive disease that could interfere with drug absorption 12. Patient who is intellectual and developmental disabled or emotionally irritable 13. Patient whose HAM-D score decreased more than 20% during placebo run-in phase 14. Patient who is taking hormone therapy or has history of hormone therapy 15. Patient who has received drug therapy or psychotherapy that meets exclusion criteria during clinical trial 16. Patient who has stressful life events or acute stress reaction (stressful life event and mental health score over 200 points at screening).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 17-item Hamilton Rating Scale for Depression (HAM-D), measured at screening, run-in phase (day -7 and if more than one week since screening), days 1, 15, 29 and 43 of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Montgomery-Asberg Depression Rating Scale, measured at days 1, 15, 29 and 43 2. Clinical Global Impression (CGI), measured at days 1, 15, 29 and 43 3. Brief version of World Health Organization Quality of Life Questionnaire (WHOQOL), measured at day 1 and 43 (start and end of treatment) 4. Visual Analogue Scale (VAS), measured at days 1, 15, 29 and 43 5. International Index of erectile function; male, measured at day 1 and 43 (start and end of treatment) 6. Female Sexual Function Index (FSFI); female, measured at day 1 and 43 (start and end of treatment) 7. Symptom Checklist-90-R (SCL-90-R), measured at day 1 and 43 (start and end of treatment) | — |
Countries
Korea, South
Outcome results
None listed