Evidence map›Paper›PMID 36847750›Full record

ArticleBrain and behavior2023

Response of peer relations and social activities to treatment with viloxazine extended-release capsules (Qelbree

Stephen V Faraone, Roberto Gomeni, Joseph T Hull, Gregory D Busse, Brendan Lujan, Jonathan Rubin, Azmi Nasser

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In one paragraph

Article in Brain and behavior, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Stephen V FaraoneDepartments of Psychiatry and of Neuroscience and Physiology, SUNY Upstate Medical University, Syracuse, New York, USA.
Roberto GomeniPharmacometrica, Lieu-dit Longcol, La Fouillade, France.
Joseph T HullSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.
Gregory D BusseSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.
Brendan LujanSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.
Jonathan RubinSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.
Azmi NasserSupernus Pharmaceuticals, Inc., Rockville, Maryland, USA.ORCID 0000-0003-0514-8410

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAttention-deficit/hyperactivity disorder (ADHD) is associated with impairments related to peer relations (PR) and social activities (SA). The objective of this post hoc analysis was to assess the degree to which viloxazine extended-release (viloxazine ER; viloxazine extended-release capsules; Qelbree

methodsData were used from four Phase III placebo-controlled trials of 100 to 600 mg/day of viloxazine ER (N = 1354; 6-17 years of age). PR and SA were measured with the Peer Relations content scale of the Conners 3rd Edition Parent Short Form's Peer Relation content scale (C3PS-PR) and the Social Activities domain of the Weiss Functional Impairment Rating Scale-Parent Report's (WFIRS-P-SA) at baseline and end of study. ADHD symptoms were assessed weekly with the ADHD Rating Scale, 5th Edition. The analyses relied on the general linear mixed model with the subject as a random effect.

resultsImprovement in C3PS-PR (p = .0035) and WFIRS-P-SA (p = .0029) scores were significantly greater in subjects treated with viloxazine ER compared with placebo. When using measures of clinically meaningful response, the C3PS-PR responder rate was significantly higher for viloxazine ER (19.2%) compared with placebo (14.1%) and the difference was statistically significant (p = .0311); the Number Needed to Treat (NNT) was 19.6. The WFIRS-P-SA responder rate was significantly higher for viloxazine ER (43.2%) compared with placebo (28.5%) and the difference was statistically significant (p < .0001); the NNT was 6.8. The standardized mean difference effect size for both PR and SA was 0.09.

conclusionsViloxazine ER significantly reduces the impairment of PR and SA in children and adolescents with ADHD. Although its effects on PR and SA are modest, many ADHD patients can be expected to achieve clinically meaningful improvements in PR and SA with viloxazine ER treatment for longer than 6 weeks.

Indexed as

Attention Deficit Disorder with HyperactivityViloxazineAdolescentChildDelayed-Action PreparationsDouble-Blind MethodHumansRandomized Controlled Trials as TopicTreatment OutcomeDelayed-Action PreparationsViloxazineattention-deficit/hyperactivity disorder (ADHD)peer relationsQelbree® (viloxazine extended-release capsules)social activities

Identifiers

PMID36847750
PMCPMC10097136

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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.