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Escitalopram in the Treatment of Depressed Elderly Patients

Received December 22, 2004; revised April 20, 2005; accepted May 4, 2005. From the Dept. of General Psychiatry, Medical University of Vienna, Vienna, Austria (SK) and H. Lundbeck A/S, International Clinical Research, Copenhagen, Denmark (HdS, HFA). Send correspondence and reprint requests to Dr. Siegfried Kasper, Dept. of General Psychiatry, Medical University of Vienna, Währinger Gürtel 18-20, A-1090, Vienna, Austria. e-mail: sci-genpsy{at}meduniwien.ac.at
© 2005 American Association for Geriatric Psychiatry

Objective: Management of depression in elderly patients presents a significant medical challenge, and there is a need for further clinical trials. The authors examined the efficacy and tolerability of escitalopram and fluoxetine versus placebo in the treatment of elderly patients with major depressive disorder (MDD). Methods: This was an 8-week, randomized, double-blind comparison of the efficacy and tolerability of escitalopram (10 mg/day) and fluoxetine (20 mg/day), to placebo in elderly patients with MDD. The prospectively defined primary efficacy parameter was the change from baseline in mean Montgomery-Åsberg Depression Rating Scale (MADRS) total score at endpoint, using last observation carried forward. Results: The intent-to-treat set comprised 517 patients; the escitalopram group included 173 patients; fluoxetine, 164 patients; and placebo, 180 patients. Mean age was 75 years, with a range of 65 to 93. Formally, this was a "failed study" (i.e., neither active treatment was superior to placebo), and the efficacy results should, therefore, be interpreted with caution. On the basis of the primary efficacy parameter, fluoxetine showed significantly lower efficacy than both escitalopram and placebo, which were not significantly different from each other. Rates of withdrawal because of adverse events/lack of efficacy were: placebo (2.8%/4.4%, respectively), escitalopram (9.8%/1.7%, respectively), and fluoxetine (12.2%/1.8%, respectively). No single adverse event occurred at an incidence 10% in escitalopram-treated patients. Conclusions: Both escitalopram and fluoxetine were well tolerated by elderly patients with MDD. Neither demonstrated superior efficacy on primary endpoint versus placebo.

Key Words: Depression • Antidepressants • SSRIs • Primary Care

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