0000000000053535

AUTHOR

Vanja Sikirica

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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Guanfacine extended release for children and adolescents with attention-deficit/hyperactivity disorder: Efficacy following prior methylphenidate trea…

2016

Guanfacine extended release (GXR) and atomoxetine (ATX) are nonstimulant treatments for attention-deficit/hyperactivity disorder (ADHD). As nonstimulant treatments are often used after stimulants in ADHD, GXR was assessed relative to prior stimulant treatment in a randomized controlled trial (RCT), in which ATX was included as a reference arm, and in the open-label phase of a randomized-withdrawal study (RWS). Participants were 6–17 years old with ADHD Rating Scale version IV (ADHD-RS-IV) scores ≥32 and Clinical Global Impressions – Severity scores ≥4. RCT participants received dose-optimized GXR (1–7 mg/day), ATX (10–100 mg/day), or placebo for 10–13 weeks. RWS participants received dose-o…

medicine.medical_specialtyNeuropsychiatric Disease and Treatmentmedicine.medical_treatmenteffectivenessmethylphenidateNeurosciences. Biological psychiatry. NeuropsychiatryPlacebolaw.invention03 medical and health sciences0302 clinical medicineRandomized controlled trialRating scalelawInternal medicinemental disordersmedicineAttention deficit hyperactivity disorderADHD0501 psychology and cognitive sciencesPsychiatryRC346-429child and adolescentguanfacineOriginal Researchbusiness.industryMethylphenidate05 social sciencesAtomoxetinetrialmedicine.disease030227 psychiatryGuanfacineinadequate respondersStimulantNeurology. Diseases of the nervous systembusinessGXRatomoxetine050104 developmental & child psychologymedicine.drugRC321-571
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Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: A randomi…

2014

AbstractGuanfacine extended-release (GXR), a selective α2A-adrenergic agonist, is a non-stimulant treatment for attention-deficit/hyperactivity disorder (ADHD). This study assessed the efficacy (symptoms and function) and safety of dose-optimized GXR compared with placebo in children and adolescents with ADHD. An atomoxetine (ATX) arm was included to provide reference data against placebo. Patients (6–17 years) were randomized at baseline to dose-optimized GXR (0.05–0.12mg/kg/day – 6–12 years: 1–4mg/day; 13–17 years: 1–7mg/day), ATX (10–100mg/day) or placebo for 4 or 7 weeks. The primary efficacy measure was change from baseline in ADHD Rating Scale version IV (ADHD-RS-IV). Key secondary me…

Malemedicine.medical_specialtyAdolescentClinical NeurologyAtomoxetine HydrochloridePlaceboDouble-Blind MethodRating scaleInternal medicineAdrenergic alpha-2 Receptor AgonistsmedicineHumansAttention deficit hyperactivity disorderPharmacology (medical)FunctionGuanfacine HydrochlorideChildAdverse effectBiological PsychiatryPsychiatric Status Rating ScalesPharmacologyAdrenergic Uptake InhibitorsDose-Response Relationship DrugPropylaminesAtomoxetinemedicine.diseaseGuanfacineGuanfacinePsychiatry and Mental healthAttention-deficit/hyperactivity disorderNeurologyTreatment efficacyAttention Deficit Disorder with HyperactivityDelayed-Action PreparationsAnesthesiaFemaleNeurology (clinical)Safetymedicine.symptomPsychologySomnolencemedicine.drugEuropean Neuropsychopharmacology
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Correlations Between Clinical Trial Outcomes Based on Symptoms, Functional Impairments, and Quality of Life in Children and Adolescents With ADHD

2017

Objective: To assess relationships between treatment-associated changes in measures of ADHD symptoms, functional impairments, and health-related quality of life in children and adolescents with ADHD. Method: Pearson correlation coefficients were calculated post hoc for changes from baseline to endpoint in outcomes of one randomized, placebo- and active-controlled trial of lisdexamfetamine (osmotic-release methylphenidate reference) and one of guanfacine extended-release (atomoxetine reference). Results: Changes in ADHD Rating Scale IV (ADHD-RS-IV) total score generally correlated moderately with changes in Child Health and Illness Profile−Child Edition: Parent Report Form (CHIP-CE:PRF) Ach…

CHIP-CEmedicine.medical_specialtyFunctional impairmentLisdexamfetamine DimesylateHRQoL03 medical and health sciences0302 clinical medicineQuality of life (healthcare)pharmacological treatmentDevelopmental and Educational PsychologymedicineAttention deficit hyperactivity disorderADHD0501 psychology and cognitive sciencesAdhd symptomsPsychiatry05 social sciencesAtomoxetineArticlesmedicine.diseaseClinical trialClinical Psychologyfunctional impairmentExtended releasePsychology030217 neurology & neurosurgery050104 developmental & child psychologymedicine.drugJournal of Attention Disorders
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EPA-0685 – Guanfacine XR (GXR) for children and adolescents with attention-deficit/hyperactivity disorder (ADHD): phase 3, randomized, double-blind, …

2014

Introduction GXR, a selective α2A-adrenergic agonist, is a non-stimulant treatment for ADHD (approved in the USA for children and adolescents and in Canada for children). Objectives To assess the efficacy (symptoms and function) and safety of dose-optimized GXR compared with placebo in children and adolescents with ADHD. Aims To evaluate the efficacy (symptom and function) and safety of GXR for the treatment of ADHD. An atomoxetine (ATX) arm was included to provide reference data against placebo (NCT01244490). Methods Patients (6–17 years) were randomly assigned at baseline to dose-optimized GXR (6–12 years, 1–4 mg/day; 13–17 years, 1–7 mg/day), ATX (10–100mg/day) or placebo for 4 or 7 week…

Pediatricsmedicine.medical_specialtyAtomoxetineVital signsmedicine.diseasePlaceboGuanfacineDouble blindPsychiatry and Mental healthmedicineAttention deficit hyperactivity disordermedicine.symptomAdverse effectPsychologySomnolencemedicine.drugEuropean Psychiatry
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