Following daily evening administration, delayed-release/extended-release methylphenidate (DR/ER-MPH) was associated with improvements in attention-deficit/hyperactivity disorder (ADHD) symptoms in children, according to results presented at Psych Congress 2019, held October 3 to 6 in San Diego, California. Researchers also saw improvements in early morning and late afternoon/evening functional impairment.
This phase 3 study trial (ClinicalTrials.gov identifier: NCT02520388) included 161 children aged 6 to 12 years (DR/ER-MPH, n=81; placebo, n=80). Patient criteria included a diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, a baseline ADHD Rating Scale IV (ADHD-RS-IV) score ≥90th percentile, and a total baseline score of ≥26, at least a partial clinical response to MPH, and impairment performing a morning routine of ≥30 minutes minimum.
The primary outcome measure was change in ADHD-RS-IV total score. Secondary end points were assessed using the Before School Functioning Questionnaire and the Parent Rating of Evening and Morning Behavior-Revised subscales after 3 weeks of treatment.
At baseline, mean ADHD-RS-IV scores were comparable in both groups (DR/ER-MPH: 43.1±7.3; placebo: 43.5±6.8). After 3 weeks, there was a greater improvement in scores for the DR/ER-MPH group compared with the placebo group (least squares mean, 24.1 vs 31.2; P =.002), with significant improvements also seen in weeks 1 and 2.
For secondary end points, children taking DR/ER-MPH showed lower least squares mean Before School Functioning Questionnaire scores (DR/ER-MPH: 18.7; placebo: 28.4; P <.001), lower early morning functional impairment scores (DR/ER-MPH: 2.1; placebo: 3.6; P <.001), and lower late afternoon/evening impairment scores (DR/ER-MPH: 9.4; placebo: 12.2; P =.002).
The most common adverse events reported by children taking DR/ER-MPH were insomnia and decreased appetite; however, they were mild or moderate in severity and largely transient.
“To our knowledge, this is the first study to demonstrate significant improvements in functional impairment in the early morning and late afternoon/evening with a single dose of a long-acting stimulant in children with ADHD,” investigators concluded.
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Disclosure: This study was supported by funding from Ironshore Pharmaceuticals & Development, Inc. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Pliszka SR, Wilens TE, Bostrom SP, et al. Efficacy and safety of a delayed-release and extended-release methylphenidate formulation in children with ADHD: results from a pivotal phase 3 trial in a naturalistic setting. Presented at: Psych Congress 2019; October 3-6, 2019; San Diego, CA. Poster 106.