Timothy E Wilens1, Keith McBurnett2, John Turnbow3, Thomas Rugino4, Carla White5, Sharon Youcha6. 1. 1 Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. 2. 2 University of California, San Francisco, San Francisco, CA, USA. 3. 3 Westex Clinical Investigations, Lubbock, TX, USA. 4. 4 Children's Specialized Hospital, Toms River, NJ, USA. 5. 5 Shire Pharmaceutical Development Ltd., Basingstoke, UK. 6. 6 Drexel University College of Medicine, Philadelphia, PA, USA; formerly of Shire Development, LLC, Wayne, PA, USA.
Abstract
OBJECTIVE: To examine efficacy and safety of adjunctive guanfacine extended release (GXR) on morning and evening ADHD symptoms using the Conners' Global Index-Parent (CGI-P) and Before-School Functioning Questionnaire (BSFQ). METHOD: Participants 6 to 17 years with ADHD ( N = 461) and suboptimal psychostimulant response were maintained on current psychostimulants and randomized to dose-optimized GXR (≤4 mg/d) in the morning (GXR AM) or evening (GXR PM), or placebo. RESULTS:CGI-P scores improved with GXR (morning assessment, GXR AM, placebo-adjusted least squares [LS] mean = -1.7, GXR PM = -2.6; evening assessment, GXR AM = -2.4, GXR PM = -3.0; all ps < .01). Parent-rated BSFQ scores reflected improved morning functioning with GXR (GXR AM, placebo-adjusted LS mean = -5.1; GXR PM = -4.7; both ps < .01). Most adverse events were mild or moderate. CONCLUSION:Adjunctive GXR AM or GXR PM was associated with improvements in morning and evening ADHD symptoms in children and adolescents.
RCT Entities:
OBJECTIVE: To examine efficacy and safety of adjunctive guanfacine extended release (GXR) on morning and evening ADHD symptoms using the Conners' Global Index-Parent (CGI-P) and Before-School Functioning Questionnaire (BSFQ). METHOD:Participants 6 to 17 years with ADHD ( N = 461) and suboptimal psychostimulant response were maintained on current psychostimulants and randomized to dose-optimized GXR (≤4 mg/d) in the morning (GXR AM) or evening (GXR PM), or placebo. RESULTS: CGI-P scores improved with GXR (morning assessment, GXR AM, placebo-adjusted least squares [LS] mean = -1.7, GXR PM = -2.6; evening assessment, GXR AM = -2.4, GXR PM = -3.0; all ps < .01). Parent-rated BSFQ scores reflected improved morning functioning with GXR (GXR AM, placebo-adjusted LS mean = -5.1; GXR PM = -4.7; both ps < .01). Most adverse events were mild or moderate. CONCLUSION: Adjunctive GXR AM or GXR PM was associated with improvements in morning and evening ADHD symptoms in children and adolescents.
Entities:
Keywords:
Intuniv; after school; before school; functioning; guanfacine XR
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