Executive Function Outcome of Treatment with Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Post-Hoc Analysis of Four Randomized Clinical Trials
| Autor: | Roberto Gomeni, Stephen V. Faraone, Zare Melyan, Gregory D. Busse, Azmi Nasser, Joseph T. Hull, Jonathan Rubin |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Adolescent Placebo behavioral disciplines and activities Viloxazine law.invention Executive Function Double-Blind Method Randomized controlled trial Rating scale law Internal medicine mental disorders Post-hoc analysis medicine Humans Attention deficit hyperactivity disorder Pharmacology (medical) Original Research Article Child Randomized Controlled Trials as Topic Dose-Response Relationship Drug business.industry medicine.disease Treatment Outcome Attention Deficit Disorder with Hyperactivity Delayed-Action Preparations Pediatrics Perinatology and Child Health Number needed to treat Central Nervous System Stimulants Extended release business medicine.drug |
| Zdroj: | Paediatric Drugs |
| ISSN: | 1179-2019 1174-5878 |
| DOI: | 10.1007/s40272-021-00470-2 |
| Popis: | Aim The aim of this study was to evaluate the effect of viloxazine extended-release capsules (viloxazine ER; Qelbree™) on executive function deficits (EFDs) in pediatric subjects (6–17 years of age) with attention-deficit/hyperactivity disorder (ADHD). Methods Data from four phase III placebo-controlled trials of 100–600 mg/day viloxazine ER (6–8 weeks of treatment) were used to evaluate the change from baseline (CFB) in the Conners 3rd Edition Parent Short Form—Executive Function (C3PS-EF) content scale T-score. Subjects were defined as EFD responders if they had C3PS-EF T-score > 70 at baseline and < 65 at end of study. ADHD symptoms were assessed with ADHD Rating Scale 5th Edition (ADHD-RS-5). Subjects were defined as ADHD symptom responders if they had a ≥ 50% reduction in CFB ADHD-RS-5 Total score at Week 6. The number needed to treat (NNT) and Cohen’s d effect sizes were estimated for EFD and ADHD symptoms. Results A total of 1154 subjects were included in the analysis. Statistically significant improvements in EFDs were observed with viloxazine ER versus placebo (p = 0.0002). There were 52.5% of EFD or ADHD symptom responders in the viloxazine ER treatment group and 35.4% in the placebo group (p |
| Databáze: | OpenAIRE |
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