Abstract | BACKGROUND: METHODS: The authors conducted a multicenter, randomized, double-blind clinical trial in which 136 children with ADHD and a chronic tic disorder were randomly administered CLON alone, MPH alone, combined CLON + MPH, or placebo (2 x 2 factorial design). Each subject participated for 16 weeks (weeks 1-4 CLON/placebo dose titration, weeks 5-8 added MPH/placebo dose titration, weeks 9-16 maintenance therapy). RESULTS: Thirty-seven children were administered MPH alone, 34 were administered CLON alone, 33 were administered CLON + MPH, and 32 were administered placebo. For our primary outcome measure of ADHD (Conners Abbreviated Symptom Questionnaire--Teacher), significant improvement occurred for subjects assigned to CLON (p < 0.002) and those assigned to MPH (p < 0.003). Compared with placebo, the greatest benefit occurred with combined CLON + MPH (p < 0.0001). CLON appeared to be most helpful for impulsivity and hyperactivity; MPH appeared to be most helpful for inattention. The proportion of individual subjects reporting a worsening of tics as an adverse effect was no higher in those treated with MPH (20%) than those being administered CLON alone (26%) or placebo (22%). Compared with placebo, measured tic severity lessened in all active treatment groups in the following order: CLON + MPH, CLON alone, MPH alone. Sedation was common with CLON treatment (28% reported moderate or severe sedation), but otherwise the drugs were tolerated well, including absence of any evident cardiac toxicity. CONCLUSIONS:
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Authors | Tourette's Syndrome Study Group |
Journal | Neurology
(Neurology)
Vol. 58
Issue 4
Pg. 527-36
(Feb 26 2002)
ISSN: 0028-3878 [Print] United States |
PMID | 11865128
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Adrenergic alpha-Agonists
- Central Nervous System Stimulants
- Methylphenidate
- Clonidine
|
Topics |
- Adolescent
- Adrenergic alpha-Agonists
(therapeutic use)
- Attention Deficit Disorder with Hyperactivity
(complications, drug therapy)
- Central Nervous System Stimulants
(therapeutic use)
- Child
- Clonidine
(therapeutic use)
- Confidence Intervals
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Humans
- Male
- Methylphenidate
(therapeutic use)
- Surveys and Questionnaires
- Tic Disorders
(complications, drug therapy)
- Treatment Outcome
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