Table 1.
Baseline demographic and clinical characteristics (intent-to-treat population)
| Placebo (N = 49) | Lurasidone 20 mg/day (N = 48) | Lurasidone 60 mg/day (N = 51) | |
|---|---|---|---|
| Male, n (%) | 40 (81.6) | 38 (79.2) | 43 (84.3) |
| Age, years | |||
| Mean (SD) | 11 (3) | 10.5 (3) | 10.5 (3) |
| 6–12, n (%) | 35 (71.4) | 36 (75.0) | 36 (70.6) |
| 13–17, n (%) | 14 (28.6) | 12 (25.0) | 15 (29.4) |
| Race, n (%) | |||
| White | 42 (86) | 34 (71) | 38 (74.5) |
| Black | 5 (10) | 10 (21) | 9 (17.6) |
| Other | 2 (4) | 4 (8) | 4 (7.8) |
| Weight (kg) | |||
| Mean (SD) | 43 (14) | 42 (17) | 44 (17) |
| Percentile, mean (SD) | 59 (27) | 57 (30) | 67 (27) |
| BMI, kg/m2 | |||
| Mean (SD) | 19.2 (3.2) | 18.8 (3.5) | 19.2 (3.3) |
| Percentile, mean (SD) | 61 (30) | 59 (29) | 64 (29) |
| Prior psychotropic medication, n (%) | |||
| Any antipsychotic | 19 (38.8) | 17 (35.4) | 16 (31.4) |
| Any psychostimulant | 18 (36.7) | 11 (22.9) | 16 (31.4) |
| Any antidepressant | 6 (12.2) | 8 (16.7) | 5 (9.8) |
| Baseline scores, mean (SD)a | |||
| ABC irritability/agitation | 29 (7) | 28 (6) | 27 (6) |
| CGI-severity | 5.0 (0.8) | 4.9 (0.8) | 4.7 (0.8) |
17 Subjects in the 60 mg/day dosing group received a non-protocol specified dose reduction to 40 mg/day at week 5
ABC aberrant behavior checklist, BMI body mass index, CGI clinical global impression, CY-BOCS Children’s Yale-Brown Obsessive–Compulsive Scale
aIntent-to-treat population