A placebo-controlled trial of risperidone in Tourette syndrome.

To evaluate the efficacy and safety of risperidone in children and adults with Tourette syndrome.
This was an 8-week, randomized, double-blind, placebo-controlled trial. The primary outcome measure was the Total Tic score of the Yale Global Tic Severity Scale (YGTSS).
Thirty-four medication-free subjects (26 children and 8 adults) ranging in age from 6 to 62 years (mean = 19.7 +/- 17.0 years) participated. YGTSS Total Tic scores were similar at baseline (26.0 +/- 5.1 for risperidone vs 27.4 +/- 8.5 for placebo). After 8 weeks of treatment (mean daily dose of 2.5 +/- 0.85), the 16 subjects on risperidone showed a 32% reduction in tic severity from baseline, compared to a 7% reduction for placebo patients (n = 18) (F[2,64] = 6.07; p = 0.004). The 12 children randomized to risperidone showed a 36% reduction in tic symptoms compared to an 11% decrease in the 14 children on placebo (F[2,48] = 6.38; p = 0.004). Two children on risperidone showed acute social phobia, which resolved with dose reduction in one subject but resulted in medication discontinuation in the other. A mean increase in body weight of 2.8 kg was observed in the risperidone group compared to no change in placebo (F[2,64] = 10.68; p = 0.0001). No extrapyramidal symptoms and no clinically significant alterations in cardiac conduction times or laboratory measures were observed.
Risperidone appears to be safe and effective for short-term treatment of tics in children or adults with Tourette syndrome. Longer-term studies are needed to evaluate the durability of efficacy and safety over time.
AuthorsL Scahill, J F Leckman, R T Schultz, L Katsovich, B S Peterson
JournalNeurology (Neurology) Vol. 60 Issue 7 Pg. 1130-5 (Apr 8 2003) ISSN: 1526-632X [Electronic] United States
PMID12682319 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Antipsychotic Agents
  • Dopamine Antagonists
  • Risperidone
  • Adolescent
  • Adult
  • Antipsychotic Agents (adverse effects, therapeutic use)
  • Body Weight (drug effects)
  • Child
  • Diagnostic Techniques, Neurological
  • Dopamine Antagonists (adverse effects, therapeutic use)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Erectile Dysfunction (chemically induced)
  • Female
  • Heart Conduction System (drug effects)
  • Humans
  • Male
  • Middle Aged
  • Phobic Disorders (chemically induced)
  • Risperidone (adverse effects, therapeutic use)
  • Severity of Illness Index
  • Tics (drug therapy, etiology)
  • Tourette Syndrome (complications, drug therapy)
  • Treatment Outcome

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