Abstract: | ABSTRACTObjective: This randomised, double-blind, fixed-dose study evaluated the efficacy of escitalopram and paroxetine in the long-term treatment of severely depressed patients with major depressive disorder (MDD).Research design and methods: Patients with a primary diagnosis of MDD and baseline Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 30 were randomised to 24 weeks of double-blind treatment with fixed doses of either escitalopram (20?mg) (n = 232) or paroxetine (40?mg) (n = 227). The primary analysis of efficacy was an analysis of covariance (ANCOVA) of change from baseline to endpoint (Week 24) in MADRS total score (last observation carried forward, LOCF).Main outcome measures; results: At endpoint (24 weeks), the mean change from baseline in MADRS total score was –25.2 for patients treated with escitalopram (n = 228) and –23.1 for patients with paroxetine (n = 223), resulting in a difference of 2.1 points (?p < 0.05). The difference in the change in the MADRS total score (LOCF) was significantly in favour of escitalopram from Week 8 onwards. The proportion of remitters (MADRS ≤ 12) after 24 weeks was 75% for escitalopram and 67% for paroxetine (?p < 0.05). The results on the primary efficacy scale were supported by significantly greater differences in favour of escitalopram on the Hamilton Anxiety, Hamilton Depression and Clinical Global Impression-Improvement and -Severity scales. For very severely depressed patients (baseline MADRS ≥ 35), there was a difference of 3.4 points at endpoint in the MADRS total score in favour of escitalopram (?p < 0.05). The overall withdrawal rate for patients treated with escitalopram (19%) was significantly lower than with paroxetine (32%) (?p < 0.01). The withdrawal rate due to adverse events was significantly lower for escitalopram (8%) compared to paroxetine (16%) (?p < 0.05). There were no significant differences in the incidence of individual adverse events during treatment.Conclusion: Escitalopram is significantly more effective than paroxetine in the long-term treatment of severely depressed patients. |