Table 2.
Efficacy endpoints (full-analysis set, mixed model for repeated measurements)
| Mean (SE) change from baseline | Mean (SE) difference vs placebo | P value | |
|---|---|---|---|
| Day 1 | |||
| MADRS-6 subscale score | −3.6 (0.6) | −0.8 (0.7) | 0.263 |
| MADRS total score | −4.8 (0.8) | −0.6 (0.9) | 0.514 |
| CGI-S score | −0.3 (0.1) | 0.1 (0.1) | 0.624 |
| CGI-I scorea | 3.3 (0.1) | −0.1 (0.2) | 0.759 |
| HADS-D subscale score | −2.6 (0.6) | 0.1 (0.7) | 0.874 |
| HADS-A subscale score | −3.4 (0.5) | −1.3 (0.7) | 0.064 |
| PGI-C scorea | 2.9 (0.3) | −0.2 (0.3) | 0.465 |
| Day 3 | |||
| MADRS-6 subscale score | −5.3 (0.8) | −0.1 (1.0) | 0.956 |
| MADRS total score | −7.5 (1.0) | 0.3 (1.3) | 0.798 |
| CGI-S score | −0.7 (0.1) | 0.0 (0.2) | 0.944 |
| CGI-I scorea | 3.1 (0.1) | −0.0 (0.2) | 0.830 |
| HADS-D subscale score | −3.6 (0.7) | 0.2 (0.9) | 0.864 |
| HADS-A subscale score | −4.1 (0.6) | −1.4 (0.7) | 0.063 |
| PGI-C scorea | 3.2 (0.3) | −0.3 (0.3) | 0.353 |
| Day 7 | |||
| MADRS-6 subscale score | −6.5 (0.9) | 0.8 (1.2) | 0.542 |
| MADRS total score | −9.4 (1.3) | 1.2 (1.7) | 0.461 |
| CGI-S score | −0.9 (0.2) | 0.1 (0.2) | 0.563 |
| CGI-I scorea | 2.8 (0.2) | −0.1 (0.2) | 0.749 |
| HADS-D subscale score | −5.1 (0.8) | 0.8 (1.1) | 0.464 |
| HADS-A subscale score | −4.4 (0.6) | −0.5 (0.7) | 0.518 |
| PGI-C scorea | 3.8 (0.3) | −0.2 (0.4) | 0.545 |
Vortioxetine, n = 39; placebo, n = 41.
CGI-S, Clinical Global Impressions – Severity of Illness; CGI-I, Clinical Global Impressions – Improvement; FAS, full-analysis set; HADS-D, Hospital Anxiety and Depression Scale – Depression; HADS-A, Hospital Anxiety and Depression Scale – Anxiety; MADRS, Montgomery–Åsberg Depression Scale; MMRM, mixed model for repeated measurements; PGI-C, patient global impression of change.
a
Absolute score. Treatment differences are based on the least squares mean.