Journal of the American Academy of Child and Adolescent Psychiatry, 2008-02, Vol.47 (2), p.189-198
2008
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Details
- Autor(en) / Beteiligte
- Titel
- Clonidine for Attention-Deficit/Hyperactivity Disorder: II. ECG Changes and Adverse Events Analysis
- Ist Teil von
- Journal of the American Academy of Child and Adolescent Psychiatry, 2008-02, Vol.47 (2), p.189-198
- Ort / Verlag
- Hagerstown, MD: Elsevier Inc
- Erscheinungsjahr
- 2008
- Quelle
- Applied Social Sciences Index & Abstracts (ASSIA)
- Beschreibungen/Notizen
- 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.
- Sprache
- Englisch
- Identifikatoren
- ISSN: 0890-8567eISSN: 1527-5418DOI: 10.1097/chi.0b013e31815d9ae4Titel-ID: cdi_proquest_miscellaneous_21134922
- Format
- –
- Schlagworte
- Adrenergic alpha-Agonists - adverse effects, Adrenergic alpha-Agonists - therapeutic use, Attention Deficit Disorder with Hyperactivity - drug therapy, Attention Deficit Disorders, Attention deficit disorders. Hyperactivity, Attention deficit hyperactivity disorder, Biological and medical sciences, Bradycardia - chemically induced, Central Nervous System Stimulants - adverse effects, Central Nervous System Stimulants - therapeutic use, Child, Child clinical studies, Children, Children & youth, Clinical outcomes, Clinical trials, clonidine, Clonidine - adverse effects, Clonidine - therapeutic use, Double-Blind Method, Drug Interactions, Drug Therapy, Drug-Related Side Effects and Adverse Reactions, electrocardiogram, Electrocardiography, Electrocardiography - drug effects, Female, Heart Rate - drug effects, Humans, Hyperactivity, Long QT Syndrome - chemically induced, Male, Medical sciences, methylphenidate, Methylphenidate - adverse effects, Methylphenidate - therapeutic use, Neuropharmacology, Outcomes of Treatment, Pediatrics, Personality Assessment, Pharmacology. Drug treatments, Psychiatry, Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer, Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease), Psychology. Psychoanalysis. Psychiatry, Psychopathology. Psychiatry, Psychopharmacology, Safety, Sleep Stages - drug effects, Tachycardia - chemically induced, tolerability