Table 1.
Escitalopram 10 mg (n = 120) | Escitalopram 20 mg (n = 119) | Escitalopram combined groups (n = 239) | Paroxetine (n = 121) | Placebo (n = 124) | |
---|---|---|---|---|---|
Total scorea | |||||
At baseline | 29.4 ± 5.8 | 29.8 ± 6.0 | 29.6 ± 5.9 | 29.8 ± 5.9 | 29.0 ± 5.6 |
At week 8 | 15.6 ± 11.0 | 16.2 ± 10.1 | 15.9 ± 10.5 | 15.6 ± 10.0 | 18.3 ± 10.1 |
Change | |||||
At week 8a | −13.7 ± 10.0 | −13.6 ± 8.8 | −13.7 ± 9.4 | −14.2 ± 9.9 | −10.7 ± 9.5 |
Difference from the placebo groupb | −3.0 | −2.7 | −2.8 | −3.2 | – |
P-valuec | 0.018 | 0.021 | 0.006 | 0.009 | – |
Difference from the paroxetine groupd | 0.3 (−2.2, 2.8) | 0.6 (−1.7, 3.0) | 0.5 (−1.6, 2.6) | – | – |
P-valuee | 0.796 | 0.612 | 0.652 | – | – |
Notes: Both escitalopram administration groups showed significant improvement compared to the placebo group. The upper limit of the 95% confidence interval for the difference between the combined escitalopram groups and the paroxetine group was below the noninferiority margin (3.2); this confirmed the noninferiority of escitalopram to paroxetine.
Mean ± SD;
least squares mean;
versus the placebo group (ANCOVA);
least squares mean (two-sided 95% confidence interval);
versus the paroxetine group (ANCOVA). The threshold limit of noninferiority is 3.2. Copyright © 2011, Seiwa Publishers. Adapted with permission from Hirayasu Y. A dose-response and non-inferiority study evaluating the efficacy and safety of escitalopram in patients with major depressive disorder: a placebo- and paroxetine-controlled, double-blind, comparative study. Jpn J Clin Psychopharmacol. 2011;14:883–899.26
Abbreviations: ANCOVA, analysis of covariance; MADRS, Montgomery–Asberg Depression Rating Scale; MDD, major depressive disorder.