Clonidine for attention-deficit/hyperactivity disorder: II. ECG changes and adverse events analysis

W. Burleson Daviss, Nick C. Patel, Adelaide S. Robb, Michael P. McDermott, Oscar G. Bukstein, William E. Pelham, Donna Palumbo, Peter Harris, Floyd R. Sallee, Lisa Burrows-MacLean, Peter Como, Martin T. Hoffman, Thomas M. Lock, Daniel Nelson, Brian McConville, Joanne Janciuras, Stephen A. Bean, Dana Raab, Francis Arnold, Heidi KippNancy Pearson, Amy Vierhile, Brad Russell, Katy Tresco, Michael Cannon, Susan Maher, David Marcus, Garrett Riggs, Irene Richard, Stephen Sulkes, Cox Christopher Cox, Roger Kurlan, Keith Conners, Robert Hunt, Karl Kieburtz, Elisabeth De Blieck, Patricia Lindsay, Larry Preston, Karen Rothenburgh, Elaine Julian-Baros, Connie Orme, Dee Kamp, Lisa Thompson

Research output: Contribution to journalArticle

69 Scopus citations

Abstract

OBJECTIVE: To examine the safety and tolerability of clonidine used alone or with methylphenidate in children with attention-deficit/hyperactivity disorder (ADHD). METHOD: In a 16-week multicenter, double-blind trial, 122 children with ADHD were randomly assigned to clonidine (n = 31), methylphenidate (n = 29), clonidine and methylphenidate (n = 32), or placebo (n = 30). Doses were flexibly titrated up to 0.6 mg/day for clonidine and 60 mg/day for methylphenidate (both with divided dosing). Groups were compared regarding adverse events and changes from baseline to week 16 in electrocardiograms and vital signs. RESULTS: There were more incidents of bradycardia in subjects treated with clonidine compared with those not treated with clonidine (17.5% versus 3.4%; p =.02), but no other significant group differences regarding electrocardiogram and other cardiovascular outcomes. There were no suggestions of interactions between clonidine and methylphenidate regarding cardiovascular outcomes. Moderate or severe adverse events were more common in subjects on clonidine (79.4% versus 49.2%; p =.0006) but not associated with higher rates of early study withdrawal. Drowsiness was common on clonidine, but generally resolved by 6 to 8 weeks. CONCLUSIONS: Clonidine, used alone or with methylphenidate, appears safe and well tolerated in childhood ADHD. Physicians prescribing clonidine should monitor for bradycardia and advise patients about the high likelihood of initial drowsiness. Copyright 2008

Original languageEnglish (US)
Pages (from-to)189-198
Number of pages10
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume47
Issue number2
DOIs
StatePublished - Feb 2008

Keywords

  • Clonidine
  • Electrocardiogram
  • Methylphenidate
  • Tolerability

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

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    Daviss, W. B., Patel, N. C., Robb, A. S., McDermott, M. P., Bukstein, O. G., Pelham, W. E., Palumbo, D., Harris, P., Sallee, F. R., Burrows-MacLean, L., Como, P., Hoffman, M. T., Lock, T. M., Nelson, D., McConville, B., Janciuras, J., Bean, S. A., Raab, D., Arnold, F., ... Thompson, L. (2008). Clonidine for attention-deficit/hyperactivity disorder: II. ECG changes and adverse events analysis. Journal of the American Academy of Child and Adolescent Psychiatry, 47(2), 189-198. https://doi.org/10.1097/chi.0b013e31815d9ae4