Methods:In this 9-week, double-blind study, patients aged 6–17 with ADHD and an inadequate response to previous methylphenidate therapy were randomized (1:1) to optimized doses of LDX or atomoxetine. Efficacy measures included ADHD Rating Scale IV (ADHD-RS-IV) total score and dichotomized Clinical Global Impressions-Improvement (CGI-I) score (improved, 1–2; not improved, 3–7).
Results:The full analysis set (n=262) comprised 194 children aged 6–12 (LDX, n=93; atomoxetine, n=101) and 68 adolescents aged 13–17 (LDX, n=34; atomoxetine, n=34). Mean optimized doses were: LDX, 52.5 (SD, 16.10) mg/day; atomoxetine, 40.2 (20.05) mg/day. Baseline mean ADHD-RS-IV total score was similar across treatment and age groups. Table shows efficacy results; safety profiles were consistent with previous studies.
| LDX | Atomoxetine |
---|
Mean change in ADHD-RS-IV total score by visit 9 (95% confidence interval) |
Overall | −26.3 (−28.4, −24.2) | −19.4 (−21.6, −17.2) |
Children | −27.5 (−29.8, −25.1) | −19.4 (−22.0, −16.7) |
Adolescents | −22.9 (−27.3, −18.5) | −19.5 (−23.7, −15.3) |
Patients (%) with improved CGI-I score by visit 9 (95% confidence interval) |
Overall | 81.7 (75.0, 88.5) | 63.6 (55.4, 71.8) |
Children | 83.9 (76.4, 91.3) | 61.2 (51.6, 70.9) |
Adolescents | 75.8 (61.1, 90.4) | 70.6 (55.3, 85.9) |