Table 3.
Mean change from baseline to weeks 8 and 12 (full-analysis set): difference between vortioxetine and agomelatine (±SE)
MMRM | ANCOVA, LOCF | |||
---|---|---|---|---|
Efficacy variable | Week 8 | Week 12 | Week 8 | Week 12 |
Primary efficacy variable | ||||
MADRS total score | −2.2 ± 0.7**a | −2.0 ± 0.7** | −3.1 ± 0.8*** | −3.5 ± 0.8*** |
Secondary efficacy variables | ||||
Clinician-rated assessments | ||||
HAM-A total score | −1.9 ± 0.6*** | −1.9 ± 0.6*** | −2.4 ± 0.6*** | −2.8 ± 0.7*** |
CGI-S score | −0.3 ± 0.1** | −0.3 ± 0.1** | −0.4 ± 0.1*** | −0.4 ± 0.1*** |
CGI-I score | −0.3 ± 0.1** | −0.3 ± 0.1** | −0.4 ± 0.1*** | −0.5 ± 0.1*** |
Patient-reported outcomes | ||||
SDS total score | −2.2 ± 0.7** | −1.8 ± 0.8* | −2.7 ± 0.7*** | −2.8 ± 0.8*** |
SDS family life subscale | −0.58 ± 0.22** | −0.43 ± 0.22 | −0.76 ± 0.22*** | −0.70 ± 0.23** |
SDS work subscale | −0.70 ± 0.25** | −0.55 ± 0.26* | −0.88 ± 0.25*** | −0.86 ± 0.26** |
SDS social life subscale | −0.66 ± 0.23** | −0.55 ± 0.22* | −0.77 ± 0.23*** | −0.76 ± 0.24** |
EQ-5D overall health state score (VAS) | 5.0 ± 1.7** | 4.7 ± 1.9* | 6.2 ± 1.7*** | 6.6 ± 1.9*** |
WLQ global productivity index | −0.01 ± 0.01* | −0.01 ± 0.01 | −0.01 ± 0.01* | −0.01 ± 0.01 |
DFFS total score | −2.9 ± 0.9** | −2.5 ± 1.0* | −2.9 ± 0.9** | −3.0 ± 1.0** |
CGI-I, Clinical Global Impression—Improvement; CGI-S, Clinical Global Impression—Severity; DFFS, Depression and Family Functioning Scale; EQ-5D, EuroQol 5 Dimensions; HAM-A, Hamilton Anxiety Rating Scale; LOCF, last observation carried forward; MADRS, Montgomery–Åsberg Depression Rating Scale; MMRM, mixed model for repeated measurements; SDS, Sheehan Disability Scale; VAS, visual analogue scale; WLQ, work limitation questionnaire; ANCOVA, analysis of covariance.
Primary efficacy analysis.
Absolute value.
*p < 0.05 versus agomelatine.
**p < 0.01 versus agomelatine.
***p < 0.001 versus agomelatine, decreased values = improvement (except for EQ-5D where increased values = improvement).