Table 1.
Demographics, Baseline Clinical Ratings, and Psychiatric History
| Parameter | Placebo + standard of care n = 113 | Esketamine 84 mg + standard of care n = 114 | Total n = 227 |
|---|---|---|---|
| Age, y | |||
| Mean (SD) |
41.4 (13.43) |
40.2 (12.73) |
40.8 (13.07) |
| Sex, n (%) | |||
| Female |
67 (59.3) |
69 (60.5) |
136 (59.9) |
| Male |
46 (40.7) |
45 (39.5) |
91 (40.1) |
| Race, n (%) | |||
| White |
87 (77.0) |
92 (80.7) |
179 (78.9) |
| Black or African American |
8 (7.1) |
7 (6.1) |
15 (6.6) |
| Asian |
2 (1.8) |
1 (0.9) |
3 (1.3) |
| Other |
16 (14.2) |
14 (12.3) |
30 (13.2) |
| MADRS total score, mean (SD) |
39.9 (5.76) |
39.5 (5.19) |
39.7 (5.48) |
| CGI-SS-r, n (%) | |||
| Normal, not at all suicidal |
0 0 |
0 0 |
0 0 |
| Questionably suicidal |
3 (2.7) |
1 (0.9) |
4 (1.8) |
| Mildly suicidal |
6 (5.3) |
10 (8.8) |
16 (7.0) |
| Moderately suicidal |
33 (29.2) |
35 (30.7) |
68 (30.0) |
| Markedly suicidal |
42 (37.2) |
48 (42.1) |
90 (39.6) |
| Severely suicidal |
28 (24.8) |
17 (14.9) |
45 (19.8) |
| Among the most extremely suicidal patients |
1 (0.9) |
3 (2.6) |
4 (1.8) |
| Prior suicide attempt, n (%) | |||
| Yes |
72 (63.7) |
78 (68.4) |
150 (66.1) |
| No |
41 (36.3) |
36 (31.6) |
77 (33.9) |
| Suicide attempt in the last month, n (%) | |||
| Yes |
24 (21.2) |
36 (31.6) |
60 (26.4) |
| No |
89 (78.8) |
78 (68.4) |
167 (73.6) |
| Standard-of-care antidepressanta, n (%) | |||
| Antidepressant monotherapy |
43 (38.1) |
45 (39.5) |
88 (38.8) |
| Antidepressant plus augmentation therapy |
70 (61.9) |
69 (60.5) |
139 (61.2) |
Abbreviations: CGI-SS-r, clinical global impression of severity of suicidality revised version; MADRS, Montgomery-Asberg Depression Rating Scale.
aAs randomized.
Note: CGI-SS-r (score ranges from 0–6; a higher score indicates a more severe condition): “Considering your total clinical experience with suicidal patients and all information now available to you, how suicidal is this patient at this time?”