Table 1.
Patient demographics and baseline characteristics (Phase B, FAS)
| Brexpiprazole | ||||
|---|---|---|---|---|
| 1 mg (n = 248) | 2 mg (n = 245) | Total (n = 493) | Placebo (n = 243) | |
| Age, years, mean (SD) | 40.9 (10.8) | 40.0 (10.7) | 40.4 (10.7) | 39.8 (10.8) |
| Sex, male, n (%) | 132 (53.2) | 143 (58.4) | 275 (55.8) | 138 (56.8) |
| BMI, kg/m2, mean (SD) | 23.5 (4.2) | 23.8 (4.6) | 23.6 (4.4) | 23.4 (4.6) |
| Duration of the current episode (months), mean (SD) | 12.2 (16.5) | 13.0 (19.1) | 12.6 (17.9) | 13.5 (22.4) |
| Number of adequate antidepressant treatments in the current episode, n (%) | ||||
| 1 | 191 (77.0) | 185 (75.5) | 376 (76.3) | 189 (77.8) |
| 2 | 49 (19.8) | 48 (19.6) | 97 (19.7) | 43 (17.7) |
| 3 | 8 (3.2) | 12 (4.9) | 20 (4.1) | 11 (4.5) |
| DSM‐5 diagnosis, n (%) | ||||
| Single episode | 95 (38.3) | 98 (40.0) | 193 (39.1) | 91 (37.4) |
| Recurrent episode | 153 (61.7) | 147 (60.0) | 300 (60.9) | 152 (62.6) |
| MADRS total score, mean (SD) | 26.7 (6.4) | 26.9 (6.9) | 26.8 (6.6) | 27.3 (6.2) |
| HAM‐D 17 total score, mean (SD) | 20.5 (4.0) | 20.8 (3.9) | 20.7 (3.9) | 21.2 (3.7) |
| CGI‐S score, mean (SD) | 4.1 (0.6) | 4.2 (0.6) | 4.1 (0.6) | 4.1 (0.6) |
Abbreviations: BMI, body mass index; CGI‐S, Clinical Global Impression‐Severity of Illness; DSM‐5, Diagnostic and Statistical Manual of Mental Disorders Fifth Edition; FAS, full analysis set; HAM‐D, Hamilton Rating Scale for Depression; MADRS, Montgomery‐Åsberg Depression Rating Scale; SD, standard deviation.