Prevention of relapse in older patients with major depressive disorder by Escitalopram treatment
Gorwood P, Weiller E, Lemming O and Katona C, Hôpital Louis Mourier, Colombes, France; H. Lundbeck A/S, Copenhagen, Denmark; Kent Institute of Medicine & Health Sciences, University of Kent, UK
Background: The present study investigated the efficacy and tolerability of escitalopram in the prevention of relapse of major depressive disorder (MDD) in older patients who had responded to acute treatment with escitalopram.
Methods: A total of 405 patients who were aged 65 years or older with a primary diagnosis of MDD (according to DSM-IV criteria) and a MADRS total score of 22 or more, received 12-week, open-label escitalopram 10 or 20mg/day treatment. Of these, 305 patients achieved remission (MADRS total score of 12 or less) and were then randomly assigned to 24 weeks of double-blind treatment with escitalopram (n=152) or placebo (n=153). The primary efficacy parameter was the time to relapse, defined as either an increase in MADRS total score to 22 or more, or lack of efficacy as judged by the investigator.
Results: The results of the primary analysis showed a clear beneficial effect of escitalopram relative to placebo on the time to relapse (log-rank test, p<0.001). The risk of relapse was 4.4 times higher for placebo- than for escitalopram-treated patients (chi-square test, p<0.001). Significantly fewer escitalopram-treated patients relapsed (9%) compared with placebo (33%) (chi-square test, p<0.001). Escitalopram was well tolerated; with 53 patients (13%) withdrawn due to adverse events during the open-label period and 3 escitalopram-treated patients and 6 placebo-treated patients during double-blind treatment (NS). The overall withdrawal rate, excluding relapses, was 7.2% for escitalopram and 8.5% for placebo during the double-blind period (NS).
Conclusion: Escitalopram was effective in preventing relapse of MDD and was well tolerated as continuation treatment by older depressed patients.
Disclosure: Dr. P Gorwood has received honoraria from H. Lundbeck A/S and Dr. C Katona is a consultant for H. Lundbeck A/S. O Lemming and Dr. E Weiller are full-time employees of H. Lundbeck A/S (ref.1).
Poster:
References:
1. Gorwood P, Weiller E, Lemming O and Katona C