Extended-release guanfacine hydrochloride in 6-17-year olds with ADHD: A randomised-withdrawal maintenance of efficacy study

Jeffrey H. Newcorn, Valerie Harpin, Michael Huss, Andrew Lyne, Vanja Sikirica, Mats Johnson, Josep Antoni Ramos-Quiroga, Judy Van Stralen, Benoit Dutray, Sasha Sreckovic, Ralph Bloomfield, Brigitte Robertson

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21 Citations (Scopus)

Abstract

© 2016 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health. Background Extended-release guanfacine hydrochloride (GXR), a selective α2A-adrenergic agonist, is a nonstimulant medication for attention-deficit/hyperactivity disorder (ADHD). This phase 3, double-blind, placebo-controlled, randomised-withdrawal study evaluated the long-term maintenance of GXR efficacy in children/adolescents with ADHD. Methods Children/adolescents (6-17 years) with ADHD received open-label GXR (1-7 mg/day). After 13 weeks, responders were randomised to GXR or placebo in the 26-week, double-blind, randomised-withdrawal phase (RWP). The primary endpoint was the percentage of treatment failure (≥50% increase in ADHD Rating Scale version IV total score and ≥2-point increase in Clinical Global Impression-Severity compared with RWP baseline, at two consecutive visits). The key secondary endpoint was time to treatment failure (TTF). Trial registration ClinicalTrials.gov identifier NCT01081145; EudraCT 2009-018161-12. Results A total of 528 participants enrolled; 316 (59.8%) entered the RWP. Treatment failure occurred in 49.3% of the GXR and 64.9% of the placebo group (p = 0.006). TTF was significantly longer in GXR versus placebo (p = 0.003). GXR was well tolerated. Conclusions Guanfacine hydrochloride demonstrated long-term maintenance of efficacy compared with placebo in children/adolescents with ADHD. Implications of the placebo substitution design and findings with different ADHD medications are discussed.
Original languageEnglish
Pages (from-to)717-728
JournalJournal of Child Psychology and Psychiatry and Allied Disciplines
Volume57
Issue number6
DOIs
Publication statusPublished - 1 Jun 2016

Keywords

  • attention-deficit/hyperactivity disorder
  • efficacy
  • guanfacine
  • Long term
  • randomised
  • withdrawal

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