6533b7cefe1ef96bd1257b12
RESEARCH PRODUCT
Extended-release guanfacine hydrochloride in 6-17-year olds with ADHD: a randomised-withdrawal maintenance of efficacy study.
Michael HussSasha SreckovicJosep Antoni Ramos-quirogaJeffrey H. NewcornBenoit DutrayR. BloomfieldMats JohnsonAndrew LyneValerie HarpinBrigitte RobertsonJudy Van StralenVanja Sikiricasubject
Malemedicine.medical_specialtyAdolescentPlacebo03 medical and health sciences0302 clinical medicineDouble-Blind MethodRating scaleInternal medicineOutcome Assessment Health CareDevelopmental and Educational PsychologymedicineClinical endpointAdrenergic alpha-2 Receptor AgonistsHumansTreatment FailureGuanfacine HydrochloridePsychiatryTrial registrationChildTime to treatment failure030227 psychiatryGuanfacinePsychiatry and Mental healthAttention Deficit Disorder with HyperactivityDelayed-Action PreparationsPediatrics Perinatology and Child HealthFemaleExtended releasePsychology030217 neurology & neurosurgeryEfficacy Studydescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2015-11-02 | Journal of child psychology and psychiatry, and allied disciplines |