Safety and Efficacy of Duloxetine Versus Venlafaxine in Major Depression in Indian Patients

The objective of the study was to compare the efficacy and safety of duloxetine and venlafaxine in major depressive disorder. The study was conducted in 26 patients suffering from major depressive disorder as per DSM-IV criteria. Patients were randomized to two groups and were given duloxetine (20,40,60mg BD) and venlafaxine (75,150,225mg OD) for 6 weeks. The primary efficacy parameter was the Hamilton Depression Rating Scale (HDRS-17). Secondary efficacy parameters included the Montgomery and Asberg depression rating scale (MADRS) and clinical global impression (CGI) scale. Safety evaluation was based on treatment emergent adverse effects and laboratory investigations. There was significant decrease in HDRS, MADRS, CGI scores from baseline to endpoint (p<0.05) in both the groups. However the difference in scores between two groups was not statistically significant. Total mean HDRS score decreased from 27(SD=2.5) to 4 (SD=1.2) in duloxetine group and from 29(SD=2.3) to 4 (SD=1.0) in venlafaxine group at the end of therapy. Response and remission rate was 96% and 69% in duloxetine group as compared to 92% and 62% in venlafaxine group respectively. There was no significant difference in adverse effects and laboratory investigation in two groups. The findings of this study indicate that duloxetine may be an effective and safe antidepressant in Indian patients of major depressive disorder. It is equally effective to venlafaxine in patients of depression.