Evaluating the safety and efficacy of PM011 as an antidepressant for patients with mild to moderate depression

INTERVENTION: 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 daily) 3. PM011, high dose 4800 mg/day (1600 mg pill x 3 times daily) 4. Placebo control, consisting of corn starch and milk sugar The trial consists of screening (visit 1), run‐in phase (visit 2/day ‐7), treatment period (visit 3/day 1, visit 4/day 15, visit 5/day 29, visit 6/day 43) and follow‐up (by telephone/day 50). The run‐in phase is during 1 week. In run‐in phase, all participants would take placebo control. The duration of treatment is 6 weeks. The total duration of the trial including follow‐up period is 9 weeks. CONDITION: Mild to moderate depression ; Mental and Behavioural Disorders ; Depressive episode PRIMARY OUTCOME: 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 OUTCOME: 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) 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