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 Lock, Daniel Nelson, Brian McConville, Joanne Janciuras, Stephen A. Bean, Dana Raab, Francis Arnold, Heidi Kipp & 23 others Nancy 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

64 Citations (Scopus)

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
Externally publishedYes

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Clonidine
Attention Deficit Disorder with Hyperactivity
Electrocardiography
Methylphenidate
Sleep Stages
Bradycardia
Vital Signs
Placebos
Physicians
Safety

Keywords

  • Clonidine
  • Electrocardiogram
  • Methylphenidate
  • Tolerability

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Developmental and Educational Psychology

Cite this

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

In: Journal of the American Academy of Child and Adolescent Psychiatry, Vol. 47, No. 2, 02.2008, p. 189-198.

Research output: Contribution to journalArticle

Daviss, WB, Patel, NC, Robb, AS, McDermott, MP, Bukstein, OG, Pelham, WE, Palumbo, D, Harris, P, Sallee, FR, Burrows-MacLean, L, Como, P, Hoffman, MT, Lock, T, Nelson, D, McConville, B, Janciuras, J, Bean, SA, Raab, D, Arnold, F, Kipp, H, Pearson, N, Vierhile, A, Russell, B, Tresco, K, Cannon, M, Maher, S, Marcus, D, Riggs, G, Richard, I, Sulkes, S, Christopher Cox, C, Kurlan, R, Conners, K, Hunt, R, Kieburtz, K, De Blieck, E, Lindsay, P, Preston, L, Rothenburgh, K, Julian-Baros, E, Orme, C, Kamp, D & 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, vol. 47, no. 2, pp. 189-198. https://doi.org/10.1097/chi.0b013e31815d9ae4
Daviss, W. Burleson ; Patel, Nick C. ; Robb, Adelaide S. ; McDermott, Michael P. ; Bukstein, Oscar G. ; Pelham, William E. ; Palumbo, Donna ; Harris, Peter ; Sallee, Floyd R. ; Burrows-MacLean, Lisa ; Como, Peter ; Hoffman, Martin T. ; Lock, Thomas ; Nelson, Daniel ; McConville, Brian ; Janciuras, Joanne ; Bean, Stephen A. ; Raab, Dana ; Arnold, Francis ; Kipp, Heidi ; Pearson, Nancy ; Vierhile, Amy ; Russell, Brad ; Tresco, Katy ; Cannon, Michael ; Maher, Susan ; Marcus, David ; Riggs, Garrett ; Richard, Irene ; Sulkes, Stephen ; Christopher Cox, Cox ; Kurlan, Roger ; Conners, Keith ; Hunt, Robert ; Kieburtz, Karl ; De Blieck, Elisabeth ; Lindsay, Patricia ; Preston, Larry ; Rothenburgh, Karen ; Julian-Baros, Elaine ; Orme, Connie ; Kamp, Dee ; Thompson, Lisa. / Clonidine for attention-deficit/hyperactivity disorder : II. ECG changes and adverse events analysis. In: Journal of the American Academy of Child and Adolescent Psychiatry. 2008 ; Vol. 47, No. 2. pp. 189-198.
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AU - Daviss, W. Burleson

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AU - Robb, Adelaide S.

AU - McDermott, Michael P.

AU - Bukstein, Oscar G.

AU - Pelham, William E.

AU - Palumbo, Donna

AU - Harris, Peter

AU - Sallee, Floyd R.

AU - Burrows-MacLean, Lisa

AU - Como, Peter

AU - Hoffman, Martin T.

AU - Lock, Thomas

AU - Nelson, Daniel

AU - McConville, Brian

AU - Janciuras, Joanne

AU - Bean, Stephen A.

AU - Raab, Dana

AU - Arnold, Francis

AU - Kipp, Heidi

AU - Pearson, Nancy

AU - Vierhile, Amy

AU - Russell, Brad

AU - Tresco, Katy

AU - Cannon, Michael

AU - Maher, Susan

AU - Marcus, David

AU - Riggs, Garrett

AU - Richard, Irene

AU - Sulkes, Stephen

AU - Christopher Cox, Cox

AU - Kurlan, Roger

AU - Conners, Keith

AU - Hunt, Robert

AU - Kieburtz, Karl

AU - De Blieck, Elisabeth

AU - Lindsay, Patricia

AU - Preston, Larry

AU - Rothenburgh, Karen

AU - Julian-Baros, Elaine

AU - Orme, Connie

AU - Kamp, Dee

AU - Thompson, Lisa

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N2 - 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

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KW - Clonidine

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