Effects of guanfacine extended release on oppositional symptoms in children aged 6-12 years with attention-deficit hyperactivity disorder and oppositional symptoms: a randomized, double-blind, placebo-controlled trial.

摘要: Objective: To evaluate the efficacy and safety of guanfacine extended release (XR, Intuniv™; Shire Development Inc., Wayne, PA, USA) in treatment oppositional symptoms children aged 6–12 years with a diagnosis attention-deficit hyperactivity disorder (ADHD) presence symptoms. Subjects Methods: In this randomized, double-blind, placebo-controlled, multicentre, flexible-dose, dose-optimization study, were randomized to receive XR (1–4mg/day) or placebo for 9 weeks. Screening washout periods followed by 5-week period, 3-week dose-maintenance period 1-week tapering period. The primary measure was change from baseline endpoint subscale Conners’ Parent Rating Scale-Revised: Long Form (CPRS-R:L) score. Change ADHD Scale IV (ADHD-RS-IV) total score secondary measure. Safety assessments included adverse events (AEs), vital signs, ECG readings laboratory studies. Results: A 217 enrolled: 138 79 placebo. Least-squares mean reductions CPRS-R:L scores 10.9 group compared 6.8 (p<0.001; effect size = 0.59). significantly greater reduction ADHD-RS-IV also seen guanfacine-treated (23.8 vs 11.5, respectively; p<0.001; 0.92). post hoc correlation analysis between percentage indicated that decreases highly correlated (r 0.74). most commonly reported, treatment-emergent AEs (TEAEs) somnolence (50.7%), headache (22.1%), sedation (13.2%), upper abdominal pain (11.8%) fatigue (11.0%) mild moderate severity. TEAEs sedation, hypersomnia experienced 62.5% subjects group. These common during dose-titration but (63.5%) resolved prior taper fatigue, lethargy asthenia reported 11.0%, 3.7% 0.0% group, respectively. Most receiving demonstrated modest changes blood pressure, pulse rate not considered clinically significant. Conclusions: population symptoms, significant observed Treatment at optimized doses associated mostly TEAEs. findings study support Clinical Trial Registration Number: NCT00367835.