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Extended‐release guanfacine hydrochloride in 6–17‐year olds with ADHD: a randomised‐withdrawal maintenance of efficacy study
Author(s) -
Newcorn Jeffrey H.,
Harpin Valerie,
Huss Michael,
Lyne Andrew,
Sikirica Vanja,
Johnson Mats,
RamosQuiroga Josep Antoni,
Stralen Judy,
Dutray Benoit,
Sreckovic Sasha,
Bloomfield Ralph,
Robertson Brigitte
Publication year - 2016
Publication title -
journal of child psychology and psychiatry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.652
H-Index - 211
eISSN - 1469-7610
pISSN - 0021-9630
DOI - 10.1111/jcpp.12492
Subject(s) - guanfacine , placebo , attention deficit hyperactivity disorder , clinical endpoint , randomized controlled trial , psychology , clinical trial , medicine , pediatrics , anesthesia , psychiatry , clonidine , alternative medicine , pathology
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 NCT 01081145; Eudra CT 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.