Table 4.
Secondary efficacy end‐points after 8 weeks (FAS; ancova using LOCF)
| Treatment group | n | LS mean (SE) | Difference versus placebo (95%CI) | P‐value |
|---|---|---|---|---|
| HAM‐D17 | ||||
| Placebo | 153 | −8.38 (0.53) | — | — |
| Vortioxetine 10 mg | 163 | −10.19 (0.52) | −1.81 (−3.29, −0.33) | 0.0165 |
| Vortioxetine 20 mg | 158 | −10.17 (0.53) | −1.79 (−3.28, −0.30) | 0.0190 |
| CGI‐I | ||||
| Placebo | 161 | 2.77 (0.09) | — | — |
| Vortioxetine 10 mg | 165 | 2.42 (0.08) | −0.36 (−0.59, −0.12) | 0.0031 |
| Vortioxetine 20 mg | 162 | 2.38 (0.09) | −0.39 (−0.63, −0.16) | 0.0011 |
| CGI‐S | ||||
| Placebo | 161 | −1.19 (0.09) | — | — |
| Vortioxetine 10 mg | 165 | −1.42 (0.09) | −0.23 (−0.47, 0.01) | 0.0609 |
| Vortioxetine 20 mg | 162 | −1.48 (0.09) | −0.29 (−0.54, −0.05) | 0.0179 |
| SDS | ||||
| Placebo | 153 | −4.43 (0.44) | — | — |
| Vortioxetine 10 mg | 163 | −4.20 (0.43) | −1.34 (−2.56, −0.12) | 0.0311 |
| Vortioxetine 20 mg | 158 | −2.85 (0.45) | −1.57 (−2.81, −0.34) | 0.0126 |
| DSST | ||||
| Placebo | 161 | 4.92 (0.63) | — | — |
| Vortioxetine 10 mg | 163 | 4.13 (0.63) | −0.79 (−2.54, 0.97) | 0.3793 |
| Vortioxetine 20 mg | 162 | 4.80 (0.63) | −0.11 (−1.86, 1.64) | 0.9011 |
| PDQ‐5 | ||||
| Placebo | 161 | −1.41 (0.23) | — | — |
| Vortioxetine 10 mg | 165 | −2.28 (0.23) | −0.87 (−1.51, −0.22) | 0.0089 |
| Vortioxetine 20 mg | 162 | −2.69 (0.23) | −1.27 (−1.92, −0.62) | 0.0001 |
ancova, analysis of covariance; CGI‐I, Clinical Global Impression of Improvement; CGI‐S, Clinical Global Impression of Severity; CI, confidence interval; DSST, Digit Symbol Substitution Test; FAS, full analysis set; HAM‐D17, Hamilton Depression Rating Scale‐17 items; LOCF, last observation carried forward; LS, least squares; PDQ‐5, Perceived Deficits Questionnaire 5‐item; SDS, Sheehan Disability Scale; SE, standard error of the mean.