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