W Burleson Daviss1, Nick C Patel1, Adelaide S Robb1, Michael P McDERMOTT1, Oscar G Bukstein1, William E Pelham1, Donna Palumbo1, Peter Harris1, Floyd R Sallee2. 1. Dr. Daviss is affiliated with University of Texas Health Science Center at San Antonio; Dr. Bukstein is with the University of Pittsburgh; Drs. Patel and Sallee are with the University of Cincinnati; Drs. McDermott, Palumbo, and Harris are with the University of Rochester; Dr. Pelham is with State University of New York at Buffalo; and Dr. Robb is with George Washington University School of Medicine and Children's National Medical Center. 2. Dr. Daviss is affiliated with University of Texas Health Science Center at San Antonio; Dr. Bukstein is with the University of Pittsburgh; Drs. Patel and Sallee are with the University of Cincinnati; Drs. McDermott, Palumbo, and Harris are with the University of Rochester; Dr. Pelham is with State University of New York at Buffalo; and Dr. Robb is with George Washington University School of Medicine and Children's National Medical Center.. Electronic address: floyd.sallee@uc.edu.
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.
RCT Entities:
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.
Authors: Michael H Bloch; Kaitlyn E Panza; Angeli Landeros-Weisenberger; James F Leckman Journal: J Am Acad Child Adolesc Psychiatry Date: 2009-09 Impact factor: 8.829
Authors: James T McCracken; James J McGough; Sandra K Loo; Jennifer Levitt; Melissa Del'Homme; Jennifer Cowen; Alexandra Sturm; Fiona Whelan; Gerhard Hellemann; Catherine Sugar; Robert M Bilder Journal: J Am Acad Child Adolesc Psychiatry Date: 2016-06-03 Impact factor: 8.829