GW320659 for the Treatment of Attention-Deficit/Hyperactivity Disorder in Children

Joseph Deveaugh-Geiss, C. Keith Conners, Elias H. Sarkis, Paul K. Winner, Lawrence D. Ginsberg, J. Michael Hemphill, Antonio Laurenza, Cathleen F. Barrows, Christopher J. Webster, Christopher J. Stotka, Mahnaz Asgharnejad

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30 Scopus citations

Abstract

Objective: To assess the safety, tolerability, and efficacy of GW320659, a chemically novel inhibitor of norepinephrine and dopamine reuptake, in pediatric attention-deficit/hyperactivity disorder (ADHD). Method: This was a multicenter, open-label, dose-titration study of seven daily dose levels of GW320659: 1.25, 2.5, 5, 7.5, 10, 12.5, and 15 mg. Treatment began with the lowest dose of GW320659 and increased weekly until subjects (mean age 9.1 years) achieved a maximum acceptable dose. Subjects remained at their maximum acceptable dose for a 4-week treatment period. The key efficacy end-point was clinical response (Clinical Global Impressions of Improvement score of 1 or 2 and an improvement of 5 or more points on at least one of the Conners Parent or Teacher Rating Scales T score). Other end-points included assessments of safety and of quality of life using the Child Health Questionnaire Parent Form 28 (CHQ-PF28). Results: Fifty-one subjects entered the titration phase and 46 subjects completed the study. During the treatment phase, these 46 subjects received a mean dose of 14.2 mg/day and the maximum exposure to GW320659 was 11 weeks. At the end of the treatment period, 76% of subjects showed improvement with GW320659 and there were significant improvements in 7 of the 12 subscales of the CHQ-PF28 compared with baseline (p < .05). Adverse events were generally mild; only five subjects required downward titration because of adverse events (three psychiatric, one neurological and urological, one cardiovascular), and no subject withdrew because of adverse events. Conclusions: GW320659 may have clinically relevant efficacy in pediatric ADHD and was well tolerated in this short-term initial study in children.

Original languageEnglish (US)
Pages (from-to)914-920
Number of pages7
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume41
Issue number8
DOIs
Publication statusPublished - Aug 2002

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Keywords

  • Attention-deficit/hyperactivity disorder
  • GW320659

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

Cite this

Deveaugh-Geiss, J., Conners, C. K., Sarkis, E. H., Winner, P. K., Ginsberg, L. D., Hemphill, J. M., ... Asgharnejad, M. (2002). GW320659 for the Treatment of Attention-Deficit/Hyperactivity Disorder in Children. Journal of the American Academy of Child and Adolescent Psychiatry, 41(8), 914-920. https://doi.org/10.1097/00004583-200208000-00009