Table 1.
Baseline Demographics and Clinical Characteristics, Safety Set
| Placebo (n = 43) | SHP465 MAS (n = 45) | |
|---|---|---|
| Mean ± SD age, years | 8.8 ± 2.03 | 8.8 ± 2.20 |
| Age category, n (%) | ||
| 6–12 years | 22 (51.2) | 22 (48.9) |
| 13–17 years | 21 (48.8) | 23 (51.1) |
| Sex, n (%) | ||
| Male | 29 (67.4) | 27 (60.0) |
| Race, n (%) | ||
| White | 28 (65.1) | 30 (66.7) |
| Black/African American | 10 (23.3) | 11 (24.4) |
| American Indian/Alaska Native | 1 (2.3) | 0 |
| Other | 4 (9.3) | 4 (8.9) |
| Mean ± SD weight, kg | 36.1 ± 17.26 | 39.3 ± 17.97 |
| Mean ± SD BMI, kg/m2 | 19.30 ± 5.575 | 20.17 ± 5.007 |
| Mean ± SD ADHD-RS-5-HV scorea | ||
| Total | 42.0 ± 7.44 | 39.9 ± 9.17 |
| Hyperactivity/impulsivity | 20.6 ± 4.41 | 18.8 ± 6.08 |
| Inattention | 21.3 ± 4.31 | 21.2 ± 4.77 |
| Mean ± SD time since ADHD diagnosis, years | 1.8 ± 1.86 | 1.8 ± 2.27 |
| ADHD subtype, n (%) | ||
| Inattentive | 2 (4.7) | 10 (22.2) |
| Hyperactive/impulsive | 5 (11.6) | 7 (15.6) |
| Combined | 36 (83.7) | 28 (62.2) |
| CGI-S, n (%)b | ||
| Moderately ill | 16 (37.2) | 16 (35.6) |
| Markedly ill | 23 (53.5) | 23 (51.1) |
| Severely ill | 2 (4.7) | 6 (13.3) |
| Among the most extremely ill | 1 (2.3) | 0 |
| Missing | 1 (2.3) | 0 |
a
Based on full analysis set (placebo, n = 42; SHP465 MAS, n = 45).
b
No participants were categorized as not assessed, normal (not at all ill), borderline mentally ill, or mildly ill.
ADHD, attention-deficit/hyperactivity disorder; ADHD-RS-5-HV, ADHD-Rating Scale, Fifth Edition, Child, Home Version; BMI, body mass index; CGI-S, Clinical Global Impressions-Severity; MAS, mixed amphetamine salts; SD, standard deviation.