Table 1.
Patient Demographics and Baseline Illness Characteristics (All Intent-to-Treat Patients)
| Placebo n=78 | Edivoxetine 0.1 n=76 | Edivoxetine 0.2 n=75 | Edivoxetine 0.3 n=75 | OROS MPHa n=36 | |
|---|---|---|---|---|---|
| Age (years) mean | 11.4 | 11.9 | 12.6 | 11.5 | 9.9 |
| Sex (% male) | 67.9 | 68.4 | 70.7 | 73.3 | 75.0 |
| Race (% white) | 76.9 | 72.4 | 76.0 | 66.7 | 69.4 |
| Prior psychostimulant use (% yes) | 43.6 | 47.4 | 49.3 | 49.3 | 0.0 |
| ADHD subtype (%) | |||||
| Combined | 71.8 | 65.8 | 66.7 | 73.3 | 83.3 |
| Hyperactive/Impulsive | 7.7 | 5.3 | 2.7 | 2.7 | 0 |
| Inattentive | 20.5 | 28.9 | 30.7 | 24.0 | 16.7 |
| Age of onset ADHD symptoms (years) mean | 4.8 | 4.8 | 4.9 | 4.7 | 4.4 |
| Age of initial ADHD diagnosis (years) mean | 8.9 | 9.2 | 9.5 | 9.1 | 8.9 |
| ODD present (% yes)b | 20.5 | 17.1 | 16.0 | 20.0 | 27.8 |
| Conduct disorder present (% yes)b | 2.6 | 2.6 | 1.3 | 2.7 | 0 |
| MDD present (% yes)b | 0 | 1.3 | 0 | 0 | 2.8 |
| GAD present (% yes)b | 1.3 | 2.6 | 1.3 | 1.3 | 0 |
a
Included only stimulant-naïve patients.
b
From K-SADS-PL.
0.1=0.1 mg/kg/day; 0.2=0.2 mg/kg/day; 0.3=0.3 mg/kg/day.
ADHD, attention deficit/hyperactivity disorder; GAD, generalized anxiety disorder; K-SADS-PL, Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children– Present and Lifetime; ODD, oppositional defiant disorder; MDD, major depressive disorder; OROS MPH, osmotic-release oral system methylphenidate.