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Psych Congress  
2018

Improvements in At-Home Functional Impairment With DR/ER-MPH in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): Post Hoc Analysis of BSFQ and PREMB-R by Norm-Referenced Cut-Offs

Authors  

Stephen Faraone, PhD – SUNY Upstate Medical University; Timothy Wilens, MD – Massachusetts General Hospital; Steven Pliszka, MD – UT Health Science Center at San Antonio; Norberto DeSousa, MA – Ironshore Pharmaceuticals & Development, Inc.; F. Randy Sallee, MD, PhD – Ironshore Pharmaceuticals & Development, Inc.; Bev Incledon, PhD – Ironshore Pharmaceuticals & Development, Inc.; Jeffrey Newcorn, MD – Mount Sinai Medical Center

Sponsor  
Ironshore Pharmaceuticals & Development, Inc.

Background: Age-adjusted cut-offs for two scales of ADHD-related at-home functional impairment, the Before School Functioning Questionnaire (BSFQ) and the Parent Rating of Evening and Morning Behavior Scale, Revised (PREMB-R), have recently been determined from a sample of U.S. youth (6–17y). Using these norm-referenced cut-offs, this post hoc analysis evaluated BSFQ and PREMB-R outcomes from a pivotal, randomized, double-blind, placebo-controlled, phase 3 trial of evening-dosed HLD200, a delayed-release and extended-release methylphenidate (DR/ER-MPH), in children (6–12y) with ADHD (NCT02520388).

Methods: BSFQ as well as PREMB-R AM and PREMB-R PM subscale scores were evaluated using the age-adjusted norm-referenced cut-offs for screening risk (80th percentile); mild (90th percentile); moderate (93rd percentile); and severe (98th percentile) at-home functional impairment at baseline and following three weeks of treatment.

Results: Most participants at baseline were at or above screening risk for at-home functional impairment by norm-referenced cut-offs in DR/ER-MPH and placebo groups (BSFQ: 98% and 96%, PREMB-R AM: 86% and 77%, PREMB-R PM: 94% and 91%, respectively). After three weeks, improvements in at-home functional impairment were more pronounced with DR/ER-MPH versus placebo. Of participants with at-home functional impairment of any severity at baseline, a greater proportion achieved “normalized” scores with DR/ER-MPH versus placebo (BSFQ: 66% vs 39%, PREMB-R AM: 72% vs 40%, PREMB-R PM: 43% vs 26%, respectively).

Conclusions: In this post hoc analysis, three weeks of DR/ER-MPH treatment resulted in more pronounced improvements across all severity levels of at-home functional impairment and more participants achieving “normalized” scores on BSFQ and PREMB-R AM/PM versus placebo.

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