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Fixed-dose trial of the single isomer SSRI escitalopram in depressed outpatients.

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 I 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.