A placebo-controlled trial of risperidone in Tourette syndrome.
OBJECTIVE
To evaluate the efficacy and safety of risperidone in children and adults with Tourette syndrome.


METHODS
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).


RESULTS
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.


CONCLUSIONS
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.
Scahill
L
L
Child Study Center, School of Nursing, Yale University, New Haven, CT 06520, USA. lawrence.scahill@yale.edu
Leckman
J F
JF
Schultz
R T
RT
Katsovich
L
L
Peterson
B S
BS
D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001835:Body Weight / Q000187:drug effects; D002648:Child; D003943:Diagnostic Techniques, Neurological; D018492:Dopamine Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000139:chemically induced; D005260:Female; D006329:Heart Conduction System / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010698:Phobic Disorders / Q000139:chemically induced; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D020323:Tics / Q000188:drug therapy* / Q000209:etiology; D005879:Tourette Syndrome / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D018492:Dopamine Antagonists; D018967:Risperidone