Table 1.
Demographics and Baseline Characteristics
| Category | Esk28 (N = 41) | Esk56 (N = 40) | Esk84 (N = 41) | Placebo (N = 80) | Total (N = 202) |
|---|---|---|---|---|---|
| Age (years) | |||||
| Mean (SD) | 45.9 (9.97) | 42.5 (8.36) | 41.9 (10.26) | 43.3 (11.40) | 43.4 (10.35) |
| Sex, n (%) | |||||
| Male | 18 (43.9%) | 24 (60.0%) | 23 (56.1%) | 41 (51.3%) | 106 (52.5%) |
| Female | 23 (56.1%) | 16 (40.0%) | 18 (43.9%) | 39 (48.8%) | 96 (47.5%) |
| Baseline BMI (kg/m2) | |||||
| Mean (SD) | 25.81 (4.733) | 24.37 (5.388) | 23.86 (3.949) | 25.01 (4.729) | 24.81 (4.735) |
| Hypertension statusa, n (%) | |||||
| Yes | 5 (12.2%) | 11 (27.5%) | 9 (22.0%) | 10 (12.5%) | 35 (17.3%) |
| No | 36 (87.8%) | 29 (72.5%) | 32 (78.0%) | 70 (87.5%) | 167 (82.7%) |
| Oral antidepressant, n (%) | |||||
| Duloxetine | 1 (2.4%) | 4 (10.0%) | 4 (9.8%) | 11 (13.8%) | 20 (9.9%) |
| Venlafaxine XR | 9 (22.0%) | 7 (17.5%) | 4 (9.8%) | 10 (12.5%) | 30 (14.9%) |
| Escitalopram | 18 (43.9%) | 11 (27.5%) | 17 (41.5%) | 25 (31.3%) | 71 (35.1%) |
| Sertraline | 8 (19.5%) | 11 (27.5%) | 10 (24.4%) | 23 (28.8%) | 52 (25.7%) |
| Paroxetine CR | 2 (4.9%) | 6 (15.0%) | 1 (2.4%) | 5 (6.3%) | 14 (6.9%) |
| Mirtazapine | 3 (7.3%) | 1 (2.5%) | 5 (12.2%) | 6 (7.5%) | 15 (7.4%) |
| Age when diagnosed with MDD (years) | |||||
| Mean (SD) | 37.9 (10.80) | 33.5 (9.51) | 32.8 (9.76) | 34.4 (11.18) | 34.6 (10.58) |
aHypertension status = Yes, if SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg at least one time point before DB Induction Phase. Hypertension status = No, if SBP < 140 mmHg and DBP < 90 mmHg at all time points before the DB Induction Phase
Abbreviations: BMI body mass index, CR controlled-release, DB double-blind, DBP diastolic blood pressure, Esk esketamine, MDD major depressive disorder, N number of patients, n subset of patients, SBP systolic blood pressure, SD standard deviation, XR extended-release