Table 4.
Change in Sleep Scores During the 1-Week Double-Blind Phase (Study 2; Evaluable Population; n = 221)
| LS mean decrease | pa | |||||
|---|---|---|---|---|---|---|
| MPH-MLR 10 mg | MPH-MLR 15 mg | MPH-MLR 20 mg | MPH-MLR 40 mg | Placebo | Treatment | |
| CSHQ | ||||||
| Total (n = 124) | −0.2 | 1.2 | 0.9 | 1.7 | 1.5 | 0.5184 |
| Bedtime Resistance | −0.2 | 0.1 | −0.2 | 0.3 | 0.2 | 0.5214 |
| Sleep Onset Delay | 0.1 | 0 | −0.1 | −0.1 | 0 | 0.7900 |
| Sleep Duration | −0.2 | 0 | −0.3 | 0 | 0 | 0.9476 |
| Sleep Anxiety | −0.2 | 0.2 | 0.1 | 0 | 0.1 | 0.4236 |
| Night Wakings | 0.1 | 0.1 | 0.1 | 0 | 0 | 0.9859 |
| Parasomnias | −0.2 | 0.5 | 0.6 | 0.1 | 0.7 | 0.0295 |
| Sleep-Disordered Breathing | −0.1 | 0.1 | 0 | 0 | 0.1 | 0.4216 |
| Daytime Sleepiness | 0.1 | 0.6 | 0.6 | 1.2 | 0.6 | 0.5483 |
| SSR | ||||||
| Total (n = 135) | −0.7 | 1.0 | 2.5 | 1.1 | 0.4 | 0.1604 |
| Bedtime | −0.3 | 0.5 | 1.1 | 0.3 | 0.7 | 0.4904 |
| Sleep Behavior | 0 | 0.2 | 0.1 | 0.3 | 0 | 0.9743 |
| Daytime Sleepiness | −0.1 | 0.4 | 0.7 | 0.4 | 0 | 0.2289 |
| ASHQ-Parent | ||||||
| Total (n = 74) | 0.9 | 4.5 | 3.9 | 4.9 | 0.9 | 0.4485 |
| Bedtime | 0 | 1.8 | 1.1 | 1.5 | −0.7 | 0.2482 |
| Sleep Behavior | 0.4 | 0 | 1.1 | 1.2 | 0.6 | 0.8334 |
| Waking During the Night | 0.4 | 0.9 | 0.9 | 0.7 | 0.7 | 0.9528 |
| Morning Waking | −0.2 | 0.2 | 0.1 | 0 | 0.1 | 0.9978 |
| Sleep Habits | −0.5 | 0.1 | 0.1 | 0.5 | −0.4 | 0.4594 |
| Daytime Sleepiness | 0.5 | 0.3 | 1.3 | 0.7 | 0.4 | 0.9418 |
| ASHQ-Self | ||||||
| Total (n = 71) | 2.9 | 10.4 | 4.5 | 5.8 | 3.2 | 0.3219 |
| Bedtime | 1.0 | 0.8 | 0.6 | 1.1 | 0.8 | 0.9966 |
| Sleep Behavior | 0.8 | 1.5 | 1.2 | 1.4 | 0.8 | 0.9677 |
| Waking During the Night | 0 | 1.5 | 0.4 | 0.6 | 0.9 | 0.4306 |
| Morning Waking | 0.8 | 2.0 | 0.3 | 0.9 | 1.1 | 0.7464 |
| Sleep Habits | −0.2 | −0.6 | 0.6 | −0.2 | −0.4 | 0.1845 |
| Daytime Sleepiness | 0.8 | 1.6 | 2.1 | 1.8 | 0.2 | 0.1853 |
a
Analysis of covariance model has fixed terms for treatment and sites; covariate is baseline score. Sites with <10 patients combined.
ASHQ, Adolescent Sleep Habits Questionnaire; CSHQ; Children's Sleep Habits Questionnaire; LS, least-squares; MPH-MLR, multilayer bead extended-release methylphenidate; SSR, Sleep Self-Report.