Table 2.
Baseline Psychiatric History
| Category | Esk28 (N = 41) | Esk56 (N = 40) | Esk84 (N = 41) | Placebo (N = 80) | Total (N = 202) |
|---|---|---|---|---|---|
| Baseline MADRS total score | |||||
| Mean (SD) | 38.4 (6.07) | 37.9 (5.41) | 35.9 (5.28) | 37.7 (5.65) | 37.5 (5.64) |
| Baseline CGI-S score | |||||
| Mean (SD) | 4.7 (0.69) | 4.7 (0.73) | 4.7 (0.75) | 4.7 (0.79) | 4.7 (0.75) |
| Baseline CGI-Sa, n (%) | |||||
| Moderately ill | 18 (43.9%) | 19 (47.5%) | 19 (46.3%) | 36 (45.0%) | 92 (45.5%) |
| Markedly ill | 18 (43.9%) | 15 (37.5%) | 15 (36.6%) | 31 (38.8%) | 79 (39.1%) |
| Severely ill | 5 (12.2%) | 6 (15.0%) | 7 (17.1%) | 11 (13.8%) | 29 (14.4%) |
| extremely ill patients | 0 | 0 | 0 | 2 (2.5%) | 2 (1.0%) |
| Baseline C-SSRSb, n (%) | |||||
| No event | 33 (80.5%) | 33 (82.5%) | 36 (87.8%) | 60 (75.0%) | 162 (80.2%) |
| Suicidal ideation | 8 (19.5%) | 7 (17.5%) | 5 (12.2%) | 20 (25.0%) | 40 (19.8%) |
| Duration of current episode at screening (weeks) | |||||
| Mean (SD) | 73.9 (115.38) | 55.5 (46.99) | 65.0 (98.93) | 61.4 (118.89) | 63.5 (103.04) |
| Number of previous treatments in current episodec, n (%) | |||||
| 2 | 19 (46.3%) | 22 (55.0%) | 21 (51.2%) | 42 (52.5%) | 104 (51.5%) |
| 3 or more | 22 (53.7%) | 18 (45.0%) | 20 (48.8%) | 38 (47.5%) | 98 (48.5%) |
| Number of episodes including current episode, n (%) | |||||
| 1 | 1 (2.4%) | 0 | 1 (2.4%) | 1 (1.3%) | 3 (1.5%) |
| 2–3 | 25 (61.0%) | 30 (75.0%) | 22 (53.7%) | 56 (70.0%) | 133 (65.8%) |
| > 3 | 15 (36.6%) | 10 (25.0%) | 18 (43.9%) | 23 (28.8%) | 66 (32.7%) |
| Had been considered to be eligible for electroconvulsive therapy, n (%) | |||||
| Yes | 10 (24.4%) | 9 (22.5%) | 11 (26.8%) | 15 (18.8%) | 45 (22.3%) |
| No | 31 (75.6%) | 28 (70.0%) | 25 (61.0%) | 62 (77.5%) | 146 (72.3%) |
| Unknown | 0 | 3 (7.5%) | 5 (12.2%) | 3 (3.8%) | 11 (5.4%) |
aThe CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a patient was assessed on severity of mental illness at the time of rating according to: 0 = not assessed; 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients
bC-SSRS category: No event = 0; Suicidal ideation = 1, 2, 3, 4, 5; Suicidal behavior = 6, 7, 8, 9, 10
cNumber of AD medications taken for at least 6 weeks during the current episode as obtained from MGH-ATRQ and plus 1 for the new oral AD taken at screening phase
Abbreviations: AD antidepressant, CGI-S Clinical Global Impression-Severity, C-SSRS Columbia-Suicide Severity Rating Scale, Esk esketamine, MADRS Montgomery-Asberg Depression Rating Scale, MGH-ATRQ Massachusetts General Hospital–Antidepressant Treatment Response Questionnaire, N number of patients, SD standard deviation