Table 1.

Comparison of changes in total MADRS scores at 8 weeks (last observation carried forward) among patients with MDD treated with escitalopram, paroxetine, or placebo

	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.

^aMean ± SD;

^bleast squares mean;

^cversus the placebo group (ANCOVA);

^dleast squares mean (two-sided 95% confidence interval);

^eversus 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.