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. 2024 Apr 1;275(6):1693–1703. doi: 10.1007/s00406-024-01783-2

Table 3.

Secondary efficacy outcomes—adjusted treatment group mean value differences for change from baseline to week 8 (primary estimand, full analysis set)

Comparison Scale Active treatment mean, 95% CI Placebo mean, 95% CI Adjusted mean value difference, 95% CI p
Silexan vs. placebo BDI-II −10.06 [−11.36; −8.76] −8.48 [−9.82; −7.13] −1.58 [−3.38; 0.22] 0.085
CGI-1 −0.95 [−1.11; −0.80] −0.78 [−0.94; −0.62] −0.18 [−0.39; 0.04] 0.111
CGI-2 2.51 [2.32; 2.70] 2.72 [2.52; 2.91] −0.21 [−0.47; 0.06] 0.127
PHQ-9 −5.1 [−5.77; −4.42] −4.26 [−4.95; −3.57] −0.84 [−1.77; 0.09] 0.077
SDS −6.07 [−7.03; −5.10] −3.67 [−4.68; −2.65] −2.40 [−3.76; −1.04]  < 0.001
Sertraline vs. placebo BDI-II −10.84 [−12.13; −9.54] −8.41 [−9.75; −7.07] −2.43 [−4.23; −0.63] 0.008
CGI-1 −1.04 [−1.19; −0.89] −0.79 [−0.94; −0.63] −0.25 [−0.46; −0.04] 0.020
CGI-2 2.37 [2.18; 2.56] 2.74 [2.55; 2.94] −0.37 [−0.63; −0.11] 0.006
PHQ-9 −5.42 [−6.05; −4.79] −4.18 [−4.83; −3.53] −1.24 [−2.12; −0.36] 0.006
SDS −4.35 [−5.39; −3.31] −3.54 [−4.60; −2.47] −0.82 [−2.26; 0.63] 0.267

CI confidence interval, BDI-II Beck depression inventory (revised), total score, CGI-1 clinical global impressions, item 1 (Severity of Illness), CGI-2 clinical global impressions, item 2 (Global Change), PHQ-9 patient health questionnaire, total score, SDS Sheehan disability scale, global impairment score