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.
Improvement in attention-deficit/hyperactivity disorder (ADHD) symptoms vs. placebo was reported in a series of pediatric clinical trials of viloxazine extended-release capsules (viloxazine ER; Qelbree™). This post hoc analysis of those studies evaluated the effect of viloxazine ER on learning and s...
| Published in: | European Child & Adolescent Psychiatry Vol. 32; no. 3; pp. 491 - 500 |
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| Main Authors: | , , , , , , |
| Format: | clinical trial research tables/charts Journal Article |
| Published: |
Springer Nature
Mar2023
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=162679572&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 162679572 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10188827 EJ3 jtl: European Child & Adolescent Psychiatry issn: 10188827 maglogo: N pubinfo: dt: Mar2023 vid: 32 iid: 3 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 162679572 152668742 162679572 162679572 10.1007/s00787-021-01877-5 162679572 ppf: 491 ppct: 9 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: 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. aug: au: Faraone, Stephen V. Gomeni, Roberto Hull, Joseph T. Busse, Gregory D. Melyan, Zare Rubin, Jonathan Nasser, Azmi affil: Departments of Psychiatry and of Neuroscience and Physiology, SUNY Upstate Medical University, Syracuse, NY, USA sug: subj: Antidepressive Agents Therapeutic Use Delayed-Action Preparations Therapeutic Use Attention Deficit Hyperactivity Disorder Drug Therapy Attention Deficit Hyperactivity Disorder Drug Therapy Learning Disorders Drug Therapy Antidepressive Agents Administration and Dosage Clinical Trials Post Hoc Analysis Human Male Female Adolescence Child Scales Multimethod Studies Chi Square Test Placebos Effect Size Data Analysis Software Descriptive Statistics Funding Source Adolescent: 13-18 years Child: 6-12 years Male Female ab: Improvement in attention-deficit/hyperactivity disorder (ADHD) symptoms vs. placebo was reported in a series of pediatric clinical trials of viloxazine extended-release capsules (viloxazine ER; Qelbree™). This post hoc analysis of those studies evaluated the effect of viloxazine ER on learning and school problems (LSPs). We used data from four Phase 3 placebo-controlled trials of 100–600 mg/day viloxazine ER (N = 1354; 6–17 years of age). LSPs were evaluated using the School domain of the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P-S) and the Learning Problems content scale of the Conners 3rd Edition-Parent Short Form (C3PS-LP) at baseline and end of study (≥ Week 6). ADHD symptoms were assessed weekly using the ADHD Rating Scale 5th Edition. The analyses were performed using the general linear mixed model with participant as a random effect. The responder analyses were performed using the Chi-square test. Viloxazine ER demonstrated significantly greater improvements in WFIRS-P-S (p < 0.0001) and C3PS-LP (p = 0.0113) scores vs. placebo. The response rate for the WFIRS-P-S was significantly greater for viloxazine ER vs. placebo (p = 0.001), and the number needed to treat (NNT) was 10.3 (effect size 0.7). Conversely, response rates for C3PS-LP did not differ between groups (p = 0.9069). In addition to ADHD symptoms improvement demonstrated in previous studies, viloxazine ER significantly reduced LSPs in pediatric subjects with ADHD. The responder analyses and NNT estimates indicate that a substantial number of children and adolescents with ADHD treated with viloxazine ER improved in clinically assessed LSPs. pubtype: Academic Journal doctype: clinical trial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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