Long-Term Effects of Risperidone in Children With Autism Spectrum Disorders: A Placebo Discontinuation Study.
Troost, Pieter W M.D.; Lahuis, Bertine E M.D.; Steenhuis, Mark-Peter M.S.; Ketelaars, Cees E. J M.D., Ph.D.; Buitelaar, Jan K M.D., Ph.D.; van Engeland, Herman M.D., Ph.D.; Scahill, Lawrence M.S.N., Ph.D.; Minderaa, Ruud B M.D., Ph.D.; Hoekstra, Pieter J M.D., Ph.D.
Journal of the American Academy of Child & Adolescent Psychiatry.
44(11):1137-1144, November 2005.
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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.
Method: 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.
Copyright 2005 (C) American Academy of Child and Adolescent Psychiatry