Table 2.
Changes from Baseline to Week 4 in ADHD-RS-IV Subscale Scores (m-ITT Population)
| Time point (week) | Treatment group | Number of pts | Change from baseline; LSM (SE) | Difference of LSM; LDX vs. placebo (95% CI) | p value |
|---|---|---|---|---|---|
| Inattention subscale score | |||||
| Week 4 | Placebo | 19 | –0.57 (1.25) | ||
| LDX 30 mg | 18 | –8.26 (1.23) | –7.69 (−11.17 to −4.22) | <0.0001 | |
| LDX 50 mg | 17 | –11.23 (1.28) | –10.66 (−14.20 to −7.12) | <0.0001 | |
| LDX 70 mg | 17 | –9.62 (1.27) | –9.05 (−12.61 to −5.48) | <0.0001 | |
| Hyperactivity/impulsivity subscale score | |||||
| Week 4 | Placebo | 19 | –1.89 (1.21) | ||
| LDX 30 mg | 18 | –8.14 (1.21) | –6.25 (−9.64 to −2.86) | 0.0005 | |
| LDX 50 mg | 17 | –7.02 (1.27) | –5.13 (−8.62 to −1.65) | 0.0046 | |
| LDX 70 mg | 17 | –7.10 (1.26) | –5.21 (−8.68 to −1.74) | 0.0038 | |
MMRM analysis: Fixed effect—treatment group, time point; Interaction effect—treatment group and time point; Covariate—each baseline ADHD-RS-IV subscale score, age (6–9 years, 10–12 years, 13–17 years); Covariance structure—unstructured.
ADHD, attention-deficit/hyperactivity disorder; CI, confidence interval; LDX, lisdexamfetamine; LSM, least-squares mean; m-ITT, modified intent-to-treat; MMRM, mixed-effects model repeated measures; pts, patients; SE, standard error.