Abstract
The results from three 8‐week escitalopram studies in major depressive disorder are presented with respect to efficacy and the effect on sleep quality, both in the full population and the subpopulation of patients with sleep problems at baseline.
Analysis of pooled data from these randomized, double‐blind, placebo‐controlled, studies in which citalopram was the active reference, showed a significant improvement for escitalopram‐treated patients (n = 52·0) in the Montgomery‐Åsberg depression rating scale (MADRS) item 4 (‘reduced sleep’) scores at weeks 6 and 8 compared with placebo (n=398; p < 0.01) and at weeks 4, 6 and 8 (n = 403; p < 0.05) compared with citalopram.
Escitalopram‐treated patients with sleep problems (MADRS item 4 score ≥ 4; n = 254) at baseline showed a statistically significant improvement in mean MADRS item 4 scores at weeks 4, 6 and 8 compared with patients treated with placebo (n = 191; p < 0.05) or citalopram (n = 193; p < 0.01). These patients also showed a statistically significant (p < 0.05) and clinically relevant improvement in MADRS total score after escitalopram treatment compared with citalopram at weeks 1, 4, 6 and 8 (observed cases) and endpoint (−2.45; last observation carried forward [LOCF]). Statistical significance in favour of escitalopram versus placebo treatment was found at all visits, including endpoint (−4.2; LOCF).
Thus, these post‐hoc analyses suggest that escitalopram has a significant beneficial effect compared with placebo or citalopram in reducing sleep disturbance in patients suffering from major depressive disorder. The effect of escitalopram in improving ‘reduced sleep’ scores was clearly seen in patients with more severe sleep disturbance at baseline. A further prospective study is needed to establish this useful clinical effect in insomniac depressives. Copyright © 2005 John Wiley & Sons, Ltd.