0000000000053527

AUTHOR

Jeffrey H. Newcorn

showing 5 related works from this author

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

2015

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 …

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 StudyJournal of child psychology and psychiatry, and allied disciplines
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Distinguishing the efficacy and sedative effects of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity diso…

2019

The present study investigated whether symptom reduction in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) treated with guanfacine extended release (GXR) can be explained by sedative effects of the medication. Data from four double-blind, randomized, placebo-controlled, phase 3 trials of GXR monotherapy (1-7 mg/day; morning administration) in children (aged 6-12 years) and adolescents (aged 13-17 years) with ADHD were analyzed post hoc. Two studies used forced-dose titration and two used flexible-dose titration. Efficacy was determined using ADHD Rating Scale IV (ADHD-RS-IV) scores. Sedative treatment-emergent adverse events (TEAEs) included somnolence, sedati…

MalePediatricsmedicine.medical_specialtyTime FactorsAdolescentmedicine.drug_classSedationDrug Administration Schedule03 medical and health sciences0302 clinical medicineDouble-Blind MethodRating scalemedicineHumansHypnotics and SedativesAttention deficit hyperactivity disorderPharmacology (medical)ChildAdverse effectBiological PsychiatryMorningPsychiatric Status Rating ScalesPharmacologyDose-Response Relationship Drugbusiness.industrymedicine.diseaseGuanfacine030227 psychiatryGuanfacinePsychiatry and Mental healthTreatment OutcomeNeurologyAttention Deficit Disorder with HyperactivityDelayed-Action PreparationsSedativeFemaleNeurology (clinical)medicine.symptombusiness030217 neurology & neurosurgerySomnolenceFollow-Up Studiesmedicine.drugEuropean Neuropsychopharmacology
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Efficacy of Guanfacine Extended Release in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant D…

2020

OBJECTIVE To assess the efficacy of the non-stimulant guanfacine extended release (GXR) on attention-deficit/hyperactivity disorder (ADHD) symptoms in children and adolescents, with and without comorbid oppositional defiant disorder (ODD). METHODS Data were derived from 4 phase 3, randomized, placebo-controlled trials of dose-optimized GXR monotherapy, in which at least 10% of participants had a diagnosis of comorbid ODD. SPD503-312 and SPD503-316 were 10- to 13-week studies of GXR (1-7 mg/d). SPD503-314 and SPD503-307 were 8-week studies of GXR (1-4 mg/d). Efficacy was assessed using the ADHD Rating Scale IV (ADHD-RS-IV) total scores. RESULTS In total, 1,084 participants were included (SPD…

Pediatricsmedicine.medical_specialtyAdolescentDouble-Blind MethodRating scalemental disordersAdrenergic alpha-2 Receptor AgonistsDevelopmental and Educational PsychologymedicineHumansAttention deficit hyperactivity disorderPooled dataChildPsychiatric Status Rating ScalesDose-Response Relationship Drugbusiness.industrymedicine.diseaseConfidence intervalGuanfacineGuanfacinePsychiatry and Mental healthTreatment OutcomeAttention Deficit Disorder with HyperactivityAttention Deficit and Disruptive Behavior DisordersDelayed-Action PreparationsOppositional defiantPediatrics Perinatology and Child HealthCore symptomsExtended releasebusinessmedicine.drugJournal of Developmental & Behavioral Pediatrics
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EPA-0666 – Long-term maintenance of efficacy of extended-release guanfacine hydrochloride (GXR) in children and adolescents with attention-deficit/hy…

2014

Introduction GXR, a selective α2A-adrenergic agonist, is a non-stimulant ADHD treatment approved in the USA for children and adolescents, and in Canada for children. Objectives To evaluate long-term maintenance of efficacy of GXR in children and adolescents with ADHD who respond to an initial open-label, short-term trial. Aims To determine if there is a higher rate of treatment failure for placebo vs GXR during the double-blind randomised-withdrawal phase (RWP) (NCT01081145). Methods Patients (6–17 years) meeting DSM-IV-TR criteria for ADHD, baseline ADHD Rating Scale-IV (ADHD-RS-IV) ≥32 and Clinical Global Impressions-Severity (CGI-S) ratings ≥4 were enrolled. Following 7-week dose optimiz…

medicine.medical_specialtyPediatricsbusiness.industryVital signsLong term maintenancemedicine.diseasePlaceboDouble blindPsychiatry and Mental healthmental disordersPhysical therapymedicineClinical endpointAttention deficit hyperactivity disorderGuanfacine HydrochlorideAdverse effectbusinessEuropean Psychiatry
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Separating efficacy and sedative effects of guanfacine extended release in children and adolescents with ADHD from four randomized, controlled, phase…

2016

IntroductionGuanfacine extended release (GXR) is a non-stimulant treatment for attention-deficit/hyperactivity disorder (ADHD).ObjectiveTo separate efficacy and sedative treatment-emergent adverse events (TEAEs) associated with GXR in four randomized, controlled trials in children (6–12 years) and adolescents (13–17 years) with ADHD.MethodsSPD503-301 (n = 345) and SPD503-304 (n = 324) were 8 and 9 week studies of fixed-dose GXR (≤ 4 mg/day). SPD503-312 (n = 314; adolescents only) and SPD503-316 (n = 338) were 10–13 week studies of dose-optimized GXR (1–7 mg/day).ResultsIn fixed-dose studies, pooled incidences of sedative TEAEs with GXR were highest at week 1 (GXR, 13.9–18.7%; placebo, 8.7%)…

business.industrymedicine.drug_classSedationPlaceboGuanfacineClinical trialPsychiatry and Mental healthAnesthesiaSedativemedicineDosingmedicine.symptomExtended releasebusinessAdverse effectmedicine.drugEuropean Psychiatry
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