IMPROVEMENTS IN EMOTIONAL LABILITY WITH DELAYED-RELEASE AND EXTENDED-RELEASE METHYLPHENIDATE TREATMENT IN CHILDREN WITH ADHD

Abstract

Emotional lability (EL) is common in individuals with ADHD, with reported prevalence rates ranging from 38% to 75%. Pharmacologic treatments for ADHD have been shown to improve EL with modest effect sizes. This post hoc analysis examined the effect of HLD200, an evening-dosed delayed-release and extended-release methylphenidate (DR/ER-MPH; tradename: JORNAY PM®), on EL in children (6-12 years) with ADHD in 2 randomized, double-blind, phase 3 trials (HLD200-107 [NCT02493777] and HLD200-108 [NCT02520388]). EL was measured with the 3-item Connors’ Global Index–Parent (CGI-P) EL subscale, which was recorded weekly in the 6-week, open-label phase of HLD200-107, and at baseline and study endpoint (Week 3) in HLD200-108. In HLD200-107, mean scores were compared to baseline at each week using paired t test (N = 117). In HLD200-108, mean scores in the DR/ER-MPH (n = 79) and placebo (n = 76) groups at Week 3 were compared using ANCOVA analysis. Correlations were determined between CGI-P EL scores and the following measures/items: Clinical Global Impression–Severity (CGI-S), CGI–Improvement (CGI-I), Caregiver Strain Questionnaire (CGSQ), and the “arguing/struggling” items in the Morning (item 3) and Evening (item 8) subscales of the Parent Rating of Evening and Morning Behavior–Revised (PREMB-R) scale. In HLD200-107, CGI-P EL scores improved after 1 week of DR/ER-MPH treatment and remained improved vs baseline in each week (p < 0.0001). In HLD200-108, CGI-P EL scores were significantly improved after 3 weeks of DR/ER-MPH treatment compared to placebo (p < 0.01). Significant positive correlations (p < 0.005) were found between CGI-P EL scores and CGSQ, CGI-S, CGI-I, and the arguing/struggling items in both the Morning and Evening subscales of the PREMB-R. DR/ER-MPH treatment improved EL scores in two phase 3 trials of children aged 6-12 years with ADHD. EL was positively correlated with ADHD symptoms and functional impairment in children with ADHD and with strain on caregivers. Due to its pharmacokinetic profile and dose-dependent duration of effect that can provide consistent treatment effects from early morning to late afternoon/evening, DR/ER-MPH is predicted to be an effective treatment for ADHD patients with EL.