Table 1.
Demographic and baseline characteristics in (A) the DB trial and (B) the OLE study (safety population)
| Characteristic | (A) DB trial (Study 237) | (B) OLE study (Study 237-EXT) | ||
|---|---|---|---|---|
| Lurasidone N = 391 |
Risperidone N = 190 |
Lurasidone–lurasidone N = 129 |
Risperidone–lurasidone N = 84 |
|
| Gender, n (%) | ||||
| Male | 290 (74.2) | 121 (63.7) | 97 (75.2) | 56 (66.7) |
| Female | 101 (25.8) | 69 (36.3) | 32 (24.8) | 28 (33.3) |
| Age, years | ||||
| Mean (SD) | 41.9 (11.3) | 41.1 (11.3) | 44.2 (10.8) | 42.5 (10.8) |
| Median (range) | 43.0 (18–73) | 43.0 (18–65) | 46.0 (19–70) | 46.0 (20–62) |
| Race, n (%) | ||||
| Black/African American | 208 (53.2) | 95 (50.0) | 64 (49.6) | 38 (45.2) |
| White | 136 (34.8) | 80 (42.1) | 46 (35.7) | 38 (45.2) |
| Asian | 17 (4.3) | 3 (1.6) | 6 (4.7) | 1 (1.2) |
| Other | 30 (7.7) | 12 (6.3) | 13 (10.1) | 7 (8.3) |
| Ethnicity, n (%) | ||||
| Not Hispanic or Latino | 312 (79.8) | 148 (77.9) | 95 (73.6) | 60 (71.4) |
| Hispanic or Latino | 79 (20.2) | 42 (22.1) | 34 (26.4) | 24 (28.6) |
| Duration of illness, years | ||||
| Mean (SD) | 3.8 (6.2)a,b | 3.5 (5.0)a | 17.1 (10.8) | 17.5 (11.8) |
| Median (range) | 1.0 (0–34)a,b | 2.0 (0–34)a | 16.0 (1–47) | 16.0 (1–42) |
| Number of prior hospitalisations, n (%) | ||||
| 0 | 83 (21.2) | 37 (19.5) | 35 (27.1) | 15 (17.9) |
| 1 | 67 (17.1) | 35 (18.4) | 24 (18.6) | 17 (20.2) |
| 2 | 57 (14.6) | 30 (15.8) | 24 (18.6) | 17 (20.2) |
| 3 | 54 (13.8) | 21 (11.1) | 18 (14.0) | 10 (11.9) |
| ≥ 4 | 130 (33.2) | 67 (35.3) | 28 (21.7) | 25 (29.8) |
| PANSS total score at DB baseline | ||||
| Mean (SD) | 65.0 (12.5) | 65.7 (12.2) | 63.8 (13.2) | 64.2 (12.7) |
| Median (range) | 65.0 (34–98) | 66.0 (34–103) | 63.0 (34–95) | 65.0 (34–103) |
| CGI-S total score at DB baseline | ||||
| Mean (SD) | 3.4 (0.6) | 3.5 (0.6) | 3.4 (0.7) | 3.5 (0.6) |
| Median (range) | 3.0 (1.0–5.0) | 4.0 (2.0–4.0) | 3.0 (1–4) | 4.0 (2–4) |
| MADRS total score at DB baseline | ||||
| Mean (SD) | 7.2 (6.8) | 8.1 (7.4) | 6.2 (6.3) | 7.0 (6.4) |
| Median (range) | 6.0 (0–34) | 6.0 (0–34) | 5.0 (0–32) | 6.0 (0–34) |
| PANSS total score at OLE baseline | ||||
| Mean (SD) | NA | NA | 55.1 (13.8) | 55.8 (11.2) |
| Median (range) | 56.0 (30–103) | 56.5 (30–78) | ||
| CGI-S total score at OLE baseline | ||||
| Mean (SD) | NA | NA | 2.8 (0.8) | 2.9 (0.8) |
| Median (range) | 3.0 (1–4) | 3.0 (1–5) | ||
| MADRS total score at OLE baseline | ||||
| Mean (SD) | NA | NA | 4.8 (5.4) | 4.4 (4.4) |
| Median (range) | 4.0 (0–33) | 4.0 (0–29) | ||
aLast acute episode to randomisation
bN = 389
CGI-S Clinical Global Impression–Severity scale, DB double-blind, MADRS Montgomery–Åsberg Depression Rating Scale, NA not applicable, OLE open-label extension, PANSS Positive and Negative Syndrome Scale, SD standard deviation