4.3 Article

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

JOURNAL OF ATTENTION DISORDERS
Volume 26, Issue 5, Pages 696-705

Publisher

SAGE PUBLICATIONS INC
DOI: 10.1177/10870547211020073

Keywords

ADHD; methylphenidate; functional impairment; BSFQ; PREMB-R

Funding

  1. Ironshore Pharmaceuticals & Development, Inc.

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By using established criteria for clinically meaningful improvements, it was found that delayed-release and extended-release methylphenidate (DR/ER-MPH) significantly improved early morning and late afternoon/evening functional impairment in children with ADHD, particularly compared to placebo.
Objective: The Before School Functioning Questionnaire and Parent Rating of Evening and Morning Behavior-Revised assess early morning (BSFQ, PREMB-R AM subscale) and late afternoon/evening (PREMB-R PM subscale) functional impairment in children with ADHD. Clinically meaningful improvements were identified and applied to a trial of delayed-release and extended-release methylphenidate (DR/ER-MPH) in children with ADHD (NCT02520388) to determine if the statistically-determined improvements in functional impairment were also clinically meaningful. Method: Clinically meaningful improvements in BSFQ/PREMB-R were established post hoc by receiver operating characteristics curves, using anchors of Clinical Global Impression-Improvement (CGI-I) = 1 and CGI-I <= 2. Percentages of participants achieving these thresholds were calculated. Results: Thresholds for CGI-I = 1/CGI-I <= 2, respectively, were 27/20 (BSFQ), 5/3 (PREMB-R AM), and 9/5 (PREMB-R PM)-point decreases. More children achieved clinically meaningful improvements with DR/ER-MPH versus placebo (all p < .05). Conclusion: DR/ER-MPH increased proportions of children achieving clinically meaningful improvements in BSFQ and PREMB-R.

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