Table 2.

Efficacy analyses (MMRM-FAS): primary outcome measure

	NSI-189 40 mg/day	NSI-189 80 mg/day	Placebo
MADRS (change from baseline)
Stage 1, mean (s.d.), n	−12.6 (11.2), 43	−11.7 (10.8), 43	−10.8 (11.1), 124
REML estimate (95% CI)	−1.8 (−5.6, 1.9)	−1.4 (−5.2, 2.3)
p value, Cohen’s d	0.342, −0.17	0.446, −0.14
Stage 2, mean (s.d.)	−3.7 (7.5), 21	−3.0 (8.1), 22	−2.0 (6.8), 22
REML estimate (95% CI),	−1.8 (−6.4, 2.7)	−1.4 (−5.9, 3.2)
p value, Cohen’s d	0.432, −0.25	0.552, −0.19
Pooled SPCD
REML estimate (95% CI)	−1.8 (−4.8, 1.1)	−-1.4 (−4.4, 1.5)
p value	0.224	0.344
MADRS responders
Stage 1, N/n (%)	16/43 (37.2)	14/43 (32.6)	41/124 (33.1)
p value	0.636	0.962
Stage 2, N (%)	2/21(9.5)	4/22 (18.2)	2/22 (9.1)
p value	0.845	0.606
SPCD p value	0.738	0.643
MADRS remitters
Stage 1, N/n (%)	9/43 (20.9)	11/43 (25.6)	23/124 (18.5)
p value	0.723	0.331
Stage 2, N/n (%)	3/21 (14.3)	4/22 (18.2)	1/22 (4.5)
p value	0.145	0.272
SPCD p value	0.134	0.178

MMRM-FAS mixed-effect model repeated measurement-full analysis set, MADRS Montgomery-Asberg Depression Rating Scale, REML estimate restricted maximal likelihood estimate, SPCD sequential-parallel comparison design