William J. Burke, Ivan Gergel, and Anjana Bose
Background: Escitalopram is the single
isomer responsible for the serotonin reuptake inhibition produced by the racemic
antidepressant citalopram. The present randomized,
double-blind, placebo-controlled, fixed-dose
multicenter trial was designed to evaluate the efficacy
and tolerability of escitalopram in the treatment
of major depressive disorder.
Method: Outpatients with an ongoing
DSM-IV major depressive episode (N=491) were randomly assigned to placebo, escitalopram,
10 mg/day, escitalopram, 20 mg/day, or citalopram, 40 mg/day, and entered an 8-week
double-blind treatment period following a 1-week
single-blind placebo lead-in. Clinical response was
evaluated by the Montgomery-Asberg Depression
Rating Scale (MADRS), the 24-item Hamilton Rating Scale for Depression (HAM-D), the
Clinical Global Impressions (CGI) scales, the
Hamilton Rating Scale for Anxiety (HAM-A), and
patient-rated quality-of-life scales.
Results: Escitalopram, at both doses,
produced significant improvement at study endpoint relative to placebo on all measures of
depression; significant separation of escitalopram
from placebo was observed within 1 week of double-blind treatment. Citalopram treatment also
significantly improved depressive symptomatology compared with placebo; however,
escitalopram, 10 mg/day, was at least as effective as
citalopram, 40 mg/day, at endpoint. Anxiety symptoms and quality of life were also
significantly improved by escitalopram compared with
placebo. The incidence of discontinuations due to adverse events for the escitalopram 10
mg/day group was not different from the placebo
group (4.2% vs. 2.5%; p=.50), and not different
for the escitalopram 20 mg/day group and the
citalopram 40 mg/day group (10.4% vs. 8.8%; p=.83).
Conclusion: Escitalopram, a single
isomer SSRI, is well-tolerated and has
demonstrated antidepressant efficacy at a dose of 10 mg/day.
J Clin Psychiatry 2002;63(4):331-336
© Copyright 2002 Physicians Postgraduate Press, Inc.