Table 1.
Demographics and Baseline Characteristics (Full Analysis Set)
| Characteristics | Placebo (n = 137) | Seltorexant | Total (n = 283) | ||
|---|---|---|---|---|---|
| 10 mg (n = 33) | 20 mg (n = 61) | 40 mg (n = 52) | |||
| Age, y | 49.6 (11.71) |
49.4 (15.31) |
48.5 (13.56) |
48.3 (10.52) |
49.1 (12.34) |
| Sex, women | 74 (54.0%) |
20 (60.6%) |
30 (49.2%) |
28 (53.8%) |
152 (53.7%) |
| Age when diagnosed with MDD, y | 38.8 (13.11) |
43.0 (16.03) |
38.9 (14.21) |
38.2 (11.41) |
39.2 (13.43) |
| Duration of current depressive episode, wk | 19.1 (12.27) |
25.7 (13.79) |
20.1 (11.02) |
21.2 (11.56) |
20.4 (12.19) |
| MADRS total score | 33.7 (5.67) |
31.7 (4.31) |
34.0 (5.03) |
34.7 (5.51) |
33.7 (5.40) |
| CGI-S score | 4.8 (0.77) |
4.6 (0.61) |
4.8 (0.67) |
4.9 (0.69) |
4.8 (0.72) |
| Current antidepressant type | |||||
| SSRI | 100 (73.0%) |
21 (63.6%) |
46 (75.4%) |
28 (53.8%) |
195 (68.9%) |
| SNRI | 37 (27.0%) |
12 (36.4%) |
15 (24.6%) |
24 (46.2%) |
88 (31.1%) |
| Baseline ISI (per IWRS) | |||||
| ≥15 | 81 (59.1%) |
5 (15.2%) |
38 (62.3%) |
39 (75.0%) |
163 (57.6%) |
| <15 | 56 (40.9%) |
28 (84.8%) |
23 (37.7%) |
13 (25.0%) |
120 (42.4%) |
| No. of major depressive episodes in lifetime, including current episode | 136 | 33 | 61 | 52 | 282 |
| 1 | 19 (14.0%) |
9 (27.3%) |
7 (11.5%) |
6 (11.5%) |
41 (14.5%) |
| 2 | 17 (12.5%) |
8 (24.2%) |
18 (29.5%) |
12 (23.1%) |
55 (19.5%) |
| ≥3 | 100 (73.5%) |
16 (48.5%) |
36 (59.0%) |
34 (65.4%) |
186 (66.0%) |
Abbreviations: CGI-S, Clinical Global Impression – Severity; ISI, Insomnia Severity Index; IWRS, interactive web response system; MADRS, Montgomery-Asberg Depression Rating Scale; MDD, major depressive disorder; SNRI, serotonin-norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor. All values are expressed as mean (SD) or n (%).