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, John Michael Hemphill, Antonio Laurenza, Cathleen F. Barrows, Christopher J. Webster, Christopher J. Stotka, Mahnaz Asgharnejad

Research output: Contribution to journalArticle

30 Citations (Scopus)

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
StatePublished - Jan 1 2002

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Attention Deficit Disorder with Hyperactivity
Dopamine Uptake Inhibitors
Pediatrics
Safety
Therapeutics
Psychiatry
Norepinephrine
Quality of Life
Child Health
Surveys and Questionnaires

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

GW320659 for the Treatment of Attention-Deficit/Hyperactivity Disorder in Children. / Deveaugh-Geiss, Joseph; Conners, C. Keith; Sarkis, Elias H.; Winner, Paul K.; Ginsberg, Lawrence D.; Hemphill, John Michael; Laurenza, Antonio; Barrows, Cathleen F.; Webster, Christopher J.; Stotka, Christopher J.; Asgharnejad, Mahnaz.

In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 41, No. 8, 01.01.2002, p. 914-920.

Research output: Contribution to journalArticle

Deveaugh-Geiss, J, Conners, CK, Sarkis, EH, Winner, PK, Ginsberg, LD, Hemphill, JM, Laurenza, A, Barrows, CF, Webster, CJ, Stotka, CJ & Asgharnejad, M 2002, 'GW320659 for the Treatment of Attention-Deficit/Hyperactivity Disorder in Children', Journal of the American Academy of Child and Adolescent Psychiatry, vol. 41, no. 8, pp. 914-920. https://doi.org/10.1097/00004583-200208000-00009
Deveaugh-Geiss, Joseph ; Conners, C. Keith ; Sarkis, Elias H. ; Winner, Paul K. ; Ginsberg, Lawrence D. ; Hemphill, John Michael ; Laurenza, Antonio ; Barrows, Cathleen F. ; Webster, Christopher J. ; Stotka, Christopher J. ; Asgharnejad, Mahnaz. / GW320659 for the Treatment of Attention-Deficit/Hyperactivity Disorder in Children. In: Journal of the American Academy of Child and Adolescent Psychiatry. 2002 ; Vol. 41, No. 8. pp. 914-920.
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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.",
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