Escitalopram in the treatment of depressed elderly patients.
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-Asberg 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 > or =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.
Kasper
Siegfried
S
Dept. of General Psychiatry, Medical University of Vienna, Währinger Gürtel 18-20, A-1090, Vienna, Austria. sci-genpsy@meduniwien.ac.at
de Swart
Hans
H
Friis Andersen
Henning
H
D000368:Aged; D000369:Aged, 80 and over; D015283:Citalopram / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use; D006801:Humans; D008297:Male; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*
D015283:Citalopram; D005473:Fluoxetine; D017367:Selective Serotonin Reuptake Inhibitors