A Phase 3, Placebo-Controlled Trial of Once-Daily Viloxazine Extended-Release Capsules in Adolescents With Attention-Deficit/Hyperactivity Disorder.
Adolescent
Adolescent Behavior
/ drug effects
Adrenergic Uptake Inhibitors
/ administration & dosage
Attention Deficit Disorder with Hyperactivity
/ diagnosis
Behavioral Symptoms
/ diagnosis
Delayed-Action Preparations
/ administration & dosage
Dose-Response Relationship, Drug
Double-Blind Method
Drug Monitoring
/ methods
Female
Humans
Male
Psychiatric Status Rating Scales
Symptom Assessment
/ methods
Treatment Outcome
Viloxazine
/ administration & dosage
Journal
Journal of clinical psychopharmacology
ISSN: 1533-712X
Titre abrégé: J Clin Psychopharmacol
Pays: United States
ID NLM: 8109496
Informations de publication
Date de publication:
Historique:
entrez:
28
6
2021
pubmed:
29
6
2021
medline:
15
12
2021
Statut:
ppublish
Résumé
This phase 3 clinical trial evaluated the efficacy and safety of viloxazine extended-release capsules (VLX-ER) as a monotherapy for attention-deficit/hyperactivity disorder (ADHD) in adolescents (12-17 years). Eligible subjects (n = 310) were randomized to receive once-daily 200 and 400 mg VLX-ER, or placebo for 6 weeks. The primary efficacy end point was change from baseline (CFB) at the end of study (EOS) in ADHD Rating Scale-5 Total score. Key secondary end points were Clinical Global Impression-Improvement score at EOS, CFB at EOS in Conners 3-Parent Short Form Composite T-score, and CFB at EOS in Weiss Functional Impairment Rating Scale-Parent Total average score. In the 200-mg/d and 400-mg/d VLX-ER treatment groups, a significant improvement was found in the CFB at EOS in ADHD Rating Scale-5 Total (P = 0.0232, P = 0.0091) and Inattention (P = 0.0424, P = 0.0390) and Hyperactivity/Impulsivity (P = 0.0069, P = 0.0005) subscale scores versus placebo. The Clinical Global Impression-Improvement score was significantly improved at EOS in the 200-mg/d and 400-mg/d VLX-ER groups versus placebo (P = 0.0042, P = 0.0003). The Conners 3-Parent Short Form composite T-score and Weiss Functional Impairment Rating Scale-Parent Total average score exhibited improvement in both VLX-ER groups; however, the difference versus placebo was not statistically significant. The most common treatment-related adverse events were somnolence, headache, decreased appetite, nausea, and fatigue. The adverse event-related discontinuation rates were <5% in all groups. Viloxazine extended-release demonstrated statistically significant and clinically meaningful improvement in ADHD symptoms in adolescents and was generally well tolerated.
Identifiants
pubmed: 34181360
doi: 10.1097/JCP.0000000000001404
pii: 00004714-202107000-00006
pmc: PMC8244935
doi:
Substances chimiques
Adrenergic Uptake Inhibitors
0
Delayed-Action Preparations
0
Viloxazine
5I5Y2789ZF
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
370-380Informations de copyright
Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.
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