Table 2. Efficacy Results at Week 8 (LS mean±SE (95% CI)) (ANCOVA, OC).
| Placebo (n=167) |
Vortioxetine 10–20 mg (n=175) |
Duloxetine 60 mg (n=187) |
|||||
|---|---|---|---|---|---|---|---|
| Change from baseline | Change from baseline | Difference from placebo | P-value | Change from baseline | Difference from placebo | P-value | |
| Primary end point | |||||||
| DSST–number of correct symbols | 2.85±0.54 | 4.60±0.53 | 1.75±0.74 (0.28;3.21) (standardized effect size 0.254) | 0.019 | 4.06±0.51 | 1.21±0.73 (−0.23;2.56) (standardized effect size 0.176) | 0.099 |
| Predefined secondary end points | |||||||
| PDQ–attention/concentration and planning/organisation* | −6.3±0.57 | −8.9±0.55 | −2.6±0.78 (−4.1;−1.0) | 0.001 | −9.3±0.53 | −3.0±0.77 (−4.5;−1.5) | <0.001 |
| CGI-I score*,** | 2.64±0.09 | 2.35±0.09 | −0.29±0.12 (−0.53;−0.05) | 0.017 | 2.24±0.08 | −0.40±0.12 (−0.64;−0.17) | <0.001 |
| Secondary end points assessing cognitive dysfunction | |||||||
| Trail Making Test A (total time, s) | −6.65 | −7.70 | −1.05 | 0.446 | −8.06 | −1.41 | 0.303 |
| Trail Making Test B (total time, s) | −9.06 | −18.73 | −9.67 | <0.001 | −14.60 | −5.54 | 0.053 |
| Stroop Congruent Test (time to completion, s) | −4.37 | −3.30 | 1.07 | 0.482 | −4.54 | −0.18 | 0.904 |
| Stroop In congruent test (time to completion, s) | −8.11 | −8.17 | −0.05 | 0.980 | −9.83 | −1.72 | 0.422 |
| Groton Maze Learning Test (total errors)† | −3.49 | −5.43 | −1.94 | 0.311 | −5.16 | −1.67 | 0.378 |
| Detection Task (Speed of Performance, Log10 msec) | −0.03 | −0.05 | −0.02 | 0.134 | −0.04 | −0.01 | 0.605 |
| Identification Task (Speed of Performance, Log10 msec) | −0.02 | −0.04 | −0.02 | 0.102 | −0.03 | −0.01 | 0.426 |
| One-Back Task (Speed of Performance, Log10 msec) | −0.02 | −0.03 | −0.01 | 0.467 | −0.02 | 0 | 0.733 |
| Additional endpoints | |||||||
| MADRS Total Score* | −12.5±0.7 | −14.8±0.7 | −2.3±1.0 (−4.3;−0.4) | 0.02 | −15.8±0.7 | −3.3±1.0 (−5.2;−1.4) | <0.001 |
| UPSA composite score | 5.07±0.59 | 8.01±0.57 | 2.94±0.81 (1.35;4.52) | <0.001 | 5.45±0.55 | 0.38±0.80 (−1.19;1.94) | 0.637 |
| UPSA–VIM composite score*** | 2.84±0.71 | 4.60±0.70 | 1.75±0.99 (−0.20;3.71) | 0.078 | 4.01±0.64 | 1.17±0.95 (−0.70;3.04) | 0.219 |
| UPSA–Brief composite score*** | 6.99±0.89 | 11.00±0.87 | 4.02±1.21 (1.63;6.41) | 0.001 | 6.64±0.88 | −0.35±1.23 (−2.76;2.06) | 0.775 |
| CPFQ total score* | −6.9±0.51 | −8.1±0.50 | −1.2±0.70 (−2.6;0.2) | 0.086 | −8.7±0.48 | −1.7±0.69 (−3.1;−0.4) | 0.012 |
| WLQ–Percentage Productivity Loss† | 3.07±0.65 | −4.41±0.64 | −1.35±0.88 (−3.08;0.39) | 0.127 | −3.80±0.64 | −0.73±0.86 (−2.44;0.97) | 0.398 |
| WLQ–Time Management† | −3.07±0.65 | −20.90±2.89 | −8.13±4.02 (−16.06;−0.20) | 0.045 | −15.30±2.99 | −2.53±4.00 (−10.42;5.36) | 0.528 |
| WLQ–Physical Demand† | −4.23±4.09 | −3.88±3.94 | 0.36±5.49 (−10.48;11.19) | 0.948 | −3.91±4.00 | 0.32±5.41 (−10.36;11.00) | 0.953 |
Abbreviations: ANCOVA, analysis of covariance; OC, observed cases.
*MMRM, FAS.
**CGI–S baseline score utilized.
***UPSA–VIM assessed in US patients and UPSA–Brief assessed in EU patients.
†WLQ scores based on a sub–group of working patients (~40% of total study population).