P0256 - Comparative study of the efficacy of acute and continuation treatment with Escitalopram versus Duloxetine in patients with major depressive disorder

Abstract

Purpose:

This study evaluated the efficacy and tolerability of escitalopram and duloxetine in the treatment of major depressive disorder (MDD).

Methods:

Patients were randomised to 24 weeks of double-blind treatment with fixed doses of escitalopram (20mg) (n=144) or duloxetine (60mg) (n=151). The primary analysis of efficacy was an ANCOVA of change from baseline to endpoint (Week 24) in MADRS total score (last observation carried forward).

Results:

At Week 8, the mean change from baseline in total MADRS score was -19.5 for escitalopram-treated patients (n=143) and -17.4 for duloxetine-treated patients (n=151), a difference of 2.1 points (p<0.05). At Week 8, the proportion of responders (at least 50% decrease in MADRS) was 69% (escitalopram) and 58% (duloxetine) (p<0.05) and remission (MADRS<=12) rates were 56% (escitalopram) and 48% (duloxetine) (NS). For the primary endpoint, the mean change from baseline in total MADRS score at Week 24 was -23.4 for escitalopram-treated patients and -21.7 for duloxetine-treated patients, a difference of 1.7 points (p=0.055, one-sided). The difference in mean change from baseline in MADRS total score favoured escitalopram at Weeks 1, 2, 4, 8, 12, and 16 (p<0.05). The overall withdrawal rates were 22% (escitalopram) and 26% (duloxetine) (NS). The withdrawal rate due to adverse events was lower for escitalopram (9%) compared to duloxetine (17%) (p<0.05) and significantly more patients treated with duloxetine reported insomnia (12.6% versus 4.9%) and constipation (8.6% versus 2.8%).

Conclusion:

Escitalopram was superior to duloxetine in acute treatment, and at least as efficacious and better tolerated in long-term treatment of MDD.