The study is designed as a multicenter, rater-blind, parallel-group, active-controlled, flexible dose, randomized trial in postmenopausal women who are recently experiencing major depressive disorder.
Patients will be female, aged 55 or older, outpatient or inpatient status, with diagnosis of major depressive episode (single or recurrent) by DSM-IV, the current depressive episode within 1 years. The patients should also have HAMD-24 total score≥20,a HAMD-24 Item 1 (depressed mood) score≥2 at screening and baseline.
The eligible subjects will be randomly assigned to 1 of 2 treatment groups with 1:1 allocation ratio: venlafaxine 75\~225mg/d or fluoxetine 20\~60mg/d. Treatment and observational duration will be 56 days (8 weeks).
Primary efficacy measure will be assessed based on the decrease of HAMD-24 from baseline to endpoint. The secondary efficacy measures are change from baseline to endpoint in CGI-S, CGI-I, and Pain VAS et al.
The safety in this study will be assessed by adverse event reporting, clinical laboratory measurements and physical examinations.
