Table 4.
MADRS total score: change from baseline to day 28 of double-blind phase of short-term randomized, controlled TRD trials by sex and treatment group
| TRANSFORM-1/TRANSFORM-2 | TRANSFORM-3 | |||||||
|---|---|---|---|---|---|---|---|---|
| Women | Men | Women | Men | |||||
| Esketamine + antidepressant |
Antidepressant + placebo |
Esketamine + antidepressant |
Antidepressant + placebo |
Esketamine + antidepressant |
Antidepressant + placebo |
Esketamine + antidepressant |
Antidepressant + placebo |
|
| Baseline | ||||||||
| N | 235 | 144 | 108 | 78 | 45 | 40 | 27 | 25 |
| Mean (SD) | 37.7 (5.49) | 37.7 (6.11) | 36.9 (5.02) | 36.7 (5.50) | 35.7 (5.90) | 34.5 (6.97) | 35.2 (6.04) | 35.1 (5.60) |
| Change to day 28 | ||||||||
| N | 215 | 138 | 95 | 70 | 39 | 36 | 24 | 24 |
| Mean (SD) | -20.3 (13.19) | -15.8 (14.67) | -18.3 (14.08) | -16.0 (14.30) | -9.9 (13.34) | -6.9 (9.65) | -10.3 (11.96) | -5.5 (7.64) |
| MMRM analysisa | ||||||||
| Diff. of LS meansb (SE) | -4.5 (1.41) | -1.6 (2.04) | -3.4 (2.41) | -5.0 (3.05) | ||||
| 95% CI on difference | -7.26, − 1.70 | -5.60, 2.41 | -8.14, 1.41 | -11.05, 1.03 | ||||
MADRS total score ranges from 0 to 60; a higher score indicates a more severe condition. Negative change in score indicates improvement. Negative difference favors esketamine. The p-values were 0.6574 and 0.3993 for sex, and 0.3546 and 0.4937 for treatment-by-sex interaction in the TRANSFORM-1/2 and TRANSFORM-3 studies, respectively
CI confidence interval; LS least squares; MADRS Montgomery-Asberg Depression Rating Scale; TRD treatment-resistant depression
aMixed model for repeated measures (MMRM) analysis with change from baseline as the response variable and the fixed effect model terms for study number (pooled only), treatment (esketamine + antidepressant, antidepressant + placebo) day, region, class of antidepressant (SNRI or SSRI), sex, and treatment-by-day, treatment-by-sex, and treatment-by-day-by-sex, and baseline value as a covariate
bEsketamine + antidepressant minus antidepressant + placebo