Extended‐release guanfacine hydrochloride in 6–17‐year olds with ADHD: a randomised‐withdrawal maintenance of efficacy study. (12th February 2016)

• Record Type: Journal Article
• Authors: Newcorn, Jeffrey H.; Harpin, Valerie; Huss, Michael; Lyne, Andrew; Sikirica, Vanja; Johnson, Mats; Ramos‐Quiroga, Josep Antoni; van Stralen, Judy; Dutray, Benoit; Sreckovic, Sasha; Bloomfield, Ralph; Robertson, Brigitte
• Is Part Of: Journal of child psychology and psychiatry and allied disciplines. Volume 57:Number 6(2016)
• Page Start: 717
• Page End: 728
• Publication Date: 2016-02-12
• Subjects: Long term -- efficacy -- randomised -- withdrawal -- attention‐deficit/hyperactivity disorder -- guanfacine; Child psychology -- Periodicals; Child psychiatry -- Periodicals; 155.4
• DOI: 10.1111/jcpp.12492
• Languages: English
• ISSNs: 0021-9630

Abstract

Abstract : 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. Abstract : Phase 3, double‐blind, placebo‐controlled, randomized‐withdrawal study evaluating the long‐term maintenance of GXR efficacy in children/adolescents with ADHD.