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

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.

Stress levels experienced by parents of children with and without attention-deficit/hyperactivity disorder during the back-to-school period: results of a European and Canadian survey.

OBJECTIVE: The back-to-school stress survey was designed to compare stress in parents of children/ adolescents with/without attention-deficit/hyperactivity disorder (ADHD) in six European countries and Canada when children prepare to return to school. METHODS: Parents of children/adolescents (6-17 years) with/without ADHD were recruited and interviewed by a consumer research organization. Parents rated potentially stress-causing situations (both standard and specifically related to the return to school) on a scale from 1 (low stress) to 10 (high stress). Mean scores were compared using Student's t-test. RESULTS: In Europe, 613/693 (mean [SD] age: 40.7 [7.0]/40.1 [6.9] years) and in Canada, 102/150 (mean [SD] age: 44.4 [8.1]/44.1 [7.2] years) parents of children with/without ADHD, respectively, participated in the survey. Children with ADHD (mean [SD] age: 11.2 [3.2]/12.6 [3.2] years in Europe/Canada) had generally similar characteristics in both samples. Parents in the ADHD group showed higher stress levels than parents in the non-ADHD group in all situations (p < 0.001 for Europe). The return to school was considered one of the most stressful events during the year. CONCLUSIONS: In Europe and Canada, ADHD has a significant impact on parental stress, particularly during the back-to-school period. This can have important implications as parental stress can affect presentation of ADHD symptoms.