Randomised study to compare the efficacy and tolerability of Duloxetine and Escitalopram in subjects with Major Depressive Disorder

Abstract

Management of depression presents a significant medical challenge. Drugs with improved efficacy and better tolerability are valuable additions to the present therapy of this disorder. Evidence suggests that therapy with a combined serotonin and noradrenaline reuptake inhibitor may be a more effective therapy of major depressive disorder (MDD) than a single neurotransmitter inhibitor. The present study assessed the efficacy and tolerability between duloxetine (dual neurotransmitter reuptake inhibitor) 40-60 mg/day and escitalopram (single neurotransmitter reuptake inhibitor) 10-20mg/day in 24 patients as an open labeled randomized study over a duration of 12 weeks. The primary efficacy measure was the mean total change in 17 items Hamilton rating scale for depression (HAMD17) from baseline to end point using the last observation carrying forward. Tolerability was evaluated by assessing discontinuation rates, adverse event rates, vital signs, and laboratory tests. In the present study, the primary analysis detected a statistically significant difference at p=.025 using Fischer’s test between duloxetine and escitalopram in both response and remission rates. There was no significant difference detected in efficacy of onset between the two study groups. Response rate, remission rate and efficacy of onset were highly significant at p<0.05 using Wilcoxon signed rank test within each group. There were a few adverse effects that were mild and self limiting with both molecules. Duloxetine is superior to escitalopram in response and remission of treatment of MDD in similar clinical setting. Both duloxetine and escitalopram are well tolerated molecules at comparable doses.