Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study.
OBJECTIVE
The short-term benefit of risperidone in ameliorating severe disruptive behavior in pediatric patients with autism spectrum disorders is well established; however, only one placebo-controlled, long-term study of efficacy is available.


METHODS
Thirty-six children with an autism spectrum disorder (5-17 years old) accompanied by severe tantrums, aggression, or self-injurious behavior, started 8-week open-label treatment with risperidone. Responders (n = 26) continued treatment for another 16 weeks, followed by a double-blind discontinuation (n = 24; two patients discontinued treatment because of weight gain) consisting of either 3 weeks of taper and 5 weeks of placebo only or continuing use of risperidone. Relapse was defined as a significant deterioration of symptoms based on clinical judgment and a parent questionnaire.


RESULTS
Risperidone was superior to placebo in preventing relapse: this occurred in 3 of 12 patients continuing on risperidone versus 8 of 12 who switched to placebo (p = .049). Weight gain, increased appetite, anxiety, and fatigue were the most frequently reported side effects.


CONCLUSIONS
This study indicates the effectiveness of risperidone during a period of several months, reducing disruptive behavior in about half of the children with autism spectrum disorders. The results provide a rationale for the continuing use of risperidone beyond 6 months, although considerable weight gain can limit the use of this agent.
Troost
Pieter W
PW
Department of Psychiatry, University Medical Center Groningen, University of Groningen, The Netherlands. p.troost@accare.nl
Lahuis
Bertine E
BE
Steenhuis
Mark-Peter
MP
Ketelaars
Cees E J
CE
Buitelaar
Jan K
JK
van Engeland
Herman
H
Scahill
Lawrence
L
Minderaa
Ruud B
RB
Hoekstra
Pieter J
PJ
D000293:Adolescent; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001321:Autistic Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D002653:Child Behavior Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D012008:Recurrence; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D018967:Risperidone