ArticlePaediatric drugs2021
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.
Article in Paediatric drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 7 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of SPN 812 (Viloxazine Extended-release Capsule) 200 and 400 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) 100 and 200 mg Efficacy and Safety in Children With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) 200 and 400 mg Efficacy and Safety in Children With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) 400 and 600 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
Who cites it
7 citing papers in PubMed, 16 citations in OpenAlex.
- A post hoc analysis of the effect of viloxazine extended-release capsules on learning and school problems in children and adolescents with attention-deficit/hyperactivity disorder.European child & adolescent psychiatry · 2023Trial
- Trial
- A Review and an Update on Pharmacological Treatment of Children With Attention-Deficit/Hyperactivity Disorder.Journal of the Korean Academy of Child and Adolescent Psychiatry · 2025Article
- Efficacy and Tolerability of Viloxazine Compared to Placebo on Emotional, Behavioral, and Executive Functioning in Children and Adolescents with ADHD: A Systematic Review and Meta-Analysis.Neuropsychiatric disease and treatment · 2025Review
- Systematic Review of Executive Function Stimulation Methods in the ADHD Population.Journal of clinical medicine · 2024Review
- A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2021.Naunyn-Schmiedeberg's archives of pharmacology · 2022Review
- Viloxazine, a Non-stimulant Norepinephrine Reuptake Inhibitor, for the Treatment of Attention Deficit Hyperactivity Disorder: A 3 Year Update.Health psychology research · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimThe 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).
methodsData 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.
resultsA 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 < 0.0001). The NNT was 5.8. The Cohen's d effect size for EFD and ADHD symptoms was 0.31.
conclusionConsistent with the efficacy of viloxazine ER demonstrated in pivotal trials, viloxazine ER significantly reduced EFDs in subjects with ADHD. Moreover, a substantial proportion of subjects treated with viloxazine ER had large improvements in EFDs, ADHD symptoms, or both. CLINICAL TRIAL REGISTRATION NUMBERS: NCT03247530, NCT03247517, NCT03247543, NCT03247556.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.