Table 1.
Baseline demographics and characteristics (safety population)
| Baseline variable | Cariprazine 3 mg (n=11) | Cariprazine 6 mg (n=16) | Cariprazine 9 mg (n=11) | Total |
|---|---|---|---|---|
| Demographics | ||||
| Race, n (%) | ||||
| Japanese | 11 (100) | 16 (100) | 11 (100) | 38 (100) |
| Age, mean (SD) (years) | 43.2 (13.2) | 43.1 (10.7) | 43.2 (13.3) | 43.1 (11.9) |
| Male, n (%) | 6 (54.5) | 7 (43.8) | 5 (45.5) | 18 (47.4) |
| Weight, mean (SD) (kg) | 70.6 (19.5) | 67.3 (16.1) | 62.8 (14.6) | 66.9 (16.5) |
| BMI, mean (SD) (kg/m2) | 25.4 (4.4) | 25.6 (4.5) | 24.3 (4.1) | 25.2 (4.3) |
| History of medical complications, n (%) | 10 (90.9) | 13 (81.3) | 10 (90.9) | 33 (86.8) |
| History of surgery, n (%) | 1 (9.1) | 0 | 0 | 1 (2.6) |
| Psychiatric characteristics | ||||
| Duration of schizophrenia, mean (SD) (years) | 14 (15.4) | 15.5 (15) | 14.6 (14.7) | 14.8 (14.6) |
| Schizophrenia subtypes, n (%) | ||||
| Paranoid | 3 (27.3) | 8 (50) | 6 (54.5) | 17 (44.7) |
| Disorganized | 1 (9.1) | 1 (6.3) | 0 (0) | 2 (5.3) |
| Catatonic | 0 (0) | 1 (6.3) | 1 (9.1) | 2 (5.3) |
| Undifferentiated | 3 (27.3) | 1 (6.3) | 0 (0) | 4 (10.5) |
| Residual | 4 (36.4) | 5 (31.3) | 4 (36.4) | 13 (34.2) |
| Psychiatric history, n (%) | ||||
| First appearance | 7 (63.6) | 6 (37.5) | 5 (45.5) | 18 (47.4) |
| Relapse | 4 (36.4) | 10 (62.5) | 5 (45.5) | 19 (50.0) |
| Unknown | 0 | 0 | 1 (9.1) | 1 (2.6) |
| Previous antipsychotic drug, n (%) | 11 (100) | 16 (100) | 11 (100) | 38 (100) |
| PANSS total, mean (SD)a | 70.5 (15.8) | 60.3 (21.8) | 75.4 (21.1) | NR |
Note:
a
Baseline PANSS values based on efficacy analysis population, which included all randomized patients with evaluable data (n=38).
Abbreviations: BMI, body mass index; NR, not reported; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation.