Objective: Post-hoc analysis of two randomized controlled trials with agomelatine was undertaken to compare data on pretreated versus untreated patients with major depressive disorder.
Method: Selected trials were Olié and Kasper (2007), a placebo-controlled trial, and Kasper et al. (2010), a randomized, double-blind comparison with sertraline.
Results: A total of 40% and 57.7% of patients had been pretreated with antidepressants in the placebo-controlled trial and sertraline-controlled trial, respectively. In the previously-treated patients in the placebo-controlled study, the mean decrease in the total score on the HAM-D₁₇ over 6 weeks was significantly greater with agomelatine than placebo (delta=4.43, P=0.005) and 67.5% of patients were responders. In the previously-treated patients of the sertraline-controlled study, the improvement on the HAM-D₁₇ total score remained numerically higher with agomelatine (delta=1.63, P=0.124), with 55.2% responders. In both studies, agomelatine was well tolerated.
Conclusion: Data from the subset of previously treated depressed patients, who can be considered more difficult to treat, indicate that agomelatine, due to its different mode of action, demonstrated antidepressant efficacy, and favorable side effect profile-with proven benefits in first-line treatment-is also an effective candidate for patients with major depressive disorder previously treated with other antidepressants.
Keywords: Agomelatine; Depression; Efficacy; Meta-analysis; Sertraline.
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