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A randomized controlled trial of clonidine added to psychostimulant medication for hyperactive and aggressive children.

AbstractOBJECTIVE:
To compare clonidine with placebo added to ongoing psychostimulant therapy for the treatment of attention-deficit/hyperactivity disorder with comorbid oppositional defiant disorder or conduct disorder.
METHOD:
Children 6 to 14 years of age recruited through 2000 to 2001 were randomized to receive clonidine syrup 0.10 to 0.20 mg/day (n = 38) or placebo (n = 29) for 6 weeks. Primary outcome measures were the Conduct and Hyperactive Index subscales of the parent-report Conners Behavior Checklist. Side effects were monitored using physiological measures and the Barkley Side Effect Rating Scale.
RESULTS:
Evaluable patient analysis showed that significantly more clonidine-treated children than controls were responders on the Conduct scale (21 of 37 versus 6 of 29; chi2(1) = 8.75, p <.01) but not the Hyperactive Index (13 of 37 versus 5 of 29). Compared with placebo, clonidine was associated with a greater reduction in systolic blood pressure measured standing and with transient sedation and dizziness. Clonidine-treated individuals had a greater reduction in a number of unwanted effects associated with psychostimulant treatment compared with placebo.
CONCLUSIONS:
The findings support the continued use of clonidine in combination with psychostimulant medication to reduce conduct symptoms associated with attention-deficit/hyperactivity disorder. Treatment is well tolerated and unwanted effects are transient.
AuthorsPhilip L Hazell, John E Stuart
JournalJournal of the American Academy of Child and Adolescent Psychiatry (J Am Acad Child Adolesc Psychiatry) Vol. 42 Issue 8 Pg. 886-94 (Aug 2003) ISSN: 0890-8567 [Print] United States
PMID12874489 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Central Nervous System Stimulants
  • Sympatholytics
  • Methylphenidate
Topics
  • Adolescent
  • Aggression
  • Attention Deficit Disorder with Hyperactivity (complications, diagnosis, drug therapy)
  • Attention Deficit and Disruptive Behavior Disorders (complications)
  • Central Nervous System Stimulants (therapeutic use)
  • Child
  • Conduct Disorder (complications)
  • Diagnostic and Statistical Manual of Mental Disorders
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Methylphenidate (therapeutic use)
  • Sympatholytics (therapeutic use)

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