NeryEmel Serap Monkul, BangsMark, LiuPeng
Oct 1, 2017
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Influential Citations
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Quality indicators
Journal
Journal of Child and Adolescent Psychopharmacology
Abstract
Abstract Objective: The purpose of this study was to assess the long-term safety and tolerability of edivoxetine, a selective norepinephrine reuptake inhibitor, which was being developed as monotherapy in pediatric attention-deficit/hyperactivity disorder (ADHD). Methods: This was an open-label study of edivoxetine once daily dosing (0.1–0.3 mg/kg) as treatment for ADHD in children (6–11 years) and adolescents (12–17 years) to assess safety for up to 5 years. The safety assessments included the incidence of adverse events, vital signs, electrocardiograms, laboratory tests, percentile changes in weight, height, and body mass index, and Tanner staging. Efficacy of treatment with edivoxetine was also assessed using the Attention-Deficit/Hyperactivity Disorder Rating Scale-Version IV-Parent Reported: Investigator Scored (ADHDRS-IV) and Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S). Results: A total of 267 children and adolescents were enrolled and 20 completed the 5-year study. Most of the participan...