Delayed- and Extended-Release Methylphenidate Improve Functional Impairment in Children with ADHD
Treatment with delayed-release and extended-release methylphenidate (DR/ER-MPH) significantly improved ADHD symptoms and functional impairment in children, according to a new study funded by Ironshore Pharmaceuticals, maker of Jornay PM.
June 11, 2021
Treatment with delayed-release and extended-release methylphenidate (DR/ER-MPH) led to clinically meaningful improvements in functional impairment in children with ADHD compared to placebo. This study, which demonstrated significant improvements in before- and after-school impairments, was published in the Journal of Attention Disorders and funded by Ironshore Pharmaceuticals, maker of Jornay PM, an ER-MPH taken at night.1
The data source for this study was a post hoc analysis based on data from a randomized, double-blind, multi-center, placebo-controlled trial of DR/ER-MPH in 161 children with diagnosed ADHD. Researchers used the Before School Functioning Questionnaire (BSFQ) to evaluate functional impairment between the time of waking up and getting to school or other morning activities and the Parent Rating of Evening and Morning Behavior Scale–Revised (PREMB-R) to assess early morning, late afternoon, and evening functional impairment. Improvements in those scales were established using anchors of Clinical Global Impression–Improvement (CGI-I) = 1 and CGI-I ≤ 2.
Following three weeks of treatment with DR/ER-MPH, the BSFQ and the two subscales of the PREMB-R demonstrated statistically significant improvements in ADHD symptoms, early-morning and late-afternoon functional impairment, and global improvement versus placebo. These thresholds of improvement were linked to clinically meaningful ratings of “very much improved” and “much/very much improved,” on the CGI-I
Researchers concluded: “Given the increasing appreciation for assessing functional impairment and improvement in ADHD coupled with the need for treatment of individuals with ADHD to extend throughout the day, future studies assessing ADHD outcomes should consider utilizing thresholds of temporal functional scales such as the BSFQ and PREMB-R, which may provide clinically meaningful differentiations beyond those of statistical significance in naturalistic settings.”
1 Wilens TE, Faraone SV, Hammerness PG, et al. Clinically Meaningful Improvements in Early Morning and Late Afternoon/Evening Functional Impairment in Children with ADHD Treated with Delayed-Release and Extended-Release Methylphenidate. Journal of Attention Disorders. June 2021. doi:10.1177/10870547211020073