Table 2.

Baseline assessments (mean ± SD) and change from baseline (mean ± SE) to week 8 (full-analysis set and mixed model for repeated measurements)

	Vortioxetine 10–20 mg (n = 252)		Agomelatine 25–50 mg (n = 241)
	Baseline assessment	Change from baseline	Baseline assessment	Change from baseline
Primary efficacy variable
MADRS total score	29.1 ± 4.4	−16.5 ± 0.48**	28.7 ± 4.0	−14.4 ± 0.51
Secondary efficacy variables
Clinician-rated assessments
HAM-A total score	21.6 ± 6.3	−11.7 ± 0.4***	21.4 ± 6.2	−9.8 ± 0.4
CGI-S score	4.4 ± 0.6	−1.84 ± 0.07**	4.4 ± 0.6	−1.55 ± 0.07
CGI-I scorea	—	1.97 ± 0.06**	—	2.22 ± 0.07
Patient-reported outcomes
SDS total score	19.2 ± 5.3	−9.28 ± 0.53**	19.3 ± 5.2	−7.06 ± 0.55
SDS family life subscale	6.3 ± 2.0	−3.09 ± 0.16**	6.4 ± 2.0	−2.51 ± 0.16
SDS work subscale	6.4 ± 2.1	−2.95 ± 0.18**	6.4 ± 2.2	−2.25 ± 0.19
SDS social life subscale	6.4 ± 2.1	−3.04 ± 0.16**	6.5 ± 2.0	−2.39 ± 0.17
EQ-5D overall health state score (VAS)	45.5 ± 18.3	20.6 ± 1.2**	46.8 ± 19.4	15.6 ± 1.3
WLQ global productivity index	0.15 ± 0.06	−0.06 ± 0.00*	0.16 ± 0.06	−0.04 ± 0.00
DFFS total score	210 ± 29	−10.8 ± 0.7**	204 ± 29	−7.9 ± 0.7

CGI-I, Clinical Global Impression—Improvement; CGI-S, Clinical Global Impression—Severity; DFFS, Depression and Family Functioning Scale; EQ-5D, EuroQol 5 Dimensions; HAM-A, Hamilton Anxiety Rating Scale; MADRS, Montgomery–Åsberg Depression Rating Scale; SDS, Sheehan Disability Scale; VAS, visual analogue scale, WLQ, work limitation questionnaire.

^aAbsolute value.

^*p < 0.05 versus agomelatine.

^**p < 0.01 versus agomelatine.

^***p < 0.001 versus agomelatine, decreased values = improvement (except for EQ-5D where increased values = improvement).