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Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study.
J Am Acad Child Adolesc Psychiatry. 2005 Nov; 44(11):1137-44.JA

Abstract

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.

Authors+Show Affiliations

Department of Psychiatry, University Medical Center Groningen, University of Groningen, The Netherlands. p.troost@accare.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16239862

Citation

Troost, Pieter W., et al. "Long-term Effects of Risperidone in Children With Autism Spectrum Disorders: a Placebo Discontinuation Study." Journal of the American Academy of Child and Adolescent Psychiatry, vol. 44, no. 11, 2005, pp. 1137-44.
Troost PW, Lahuis BE, Steenhuis MP, et al. Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study. J Am Acad Child Adolesc Psychiatry. 2005;44(11):1137-44.
Troost, P. W., Lahuis, B. E., Steenhuis, M. P., Ketelaars, C. E., Buitelaar, J. K., van Engeland, H., Scahill, L., Minderaa, R. B., & Hoekstra, P. J. (2005). Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study. Journal of the American Academy of Child and Adolescent Psychiatry, 44(11), 1137-44.
Troost PW, et al. Long-term Effects of Risperidone in Children With Autism Spectrum Disorders: a Placebo Discontinuation Study. J Am Acad Child Adolesc Psychiatry. 2005;44(11):1137-44. PubMed PMID: 16239862.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study. AU - Troost,Pieter W, AU - Lahuis,Bertine E, AU - Steenhuis,Mark-Peter, AU - Ketelaars,Cees E J, AU - Buitelaar,Jan K, AU - van Engeland,Herman, AU - Scahill,Lawrence, AU - Minderaa,Ruud B, AU - Hoekstra,Pieter J, PY - 2005/10/22/pubmed PY - 2005/12/24/medline PY - 2005/10/22/entrez SP - 1137 EP - 44 JF - Journal of the American Academy of Child and Adolescent Psychiatry JO - J Am Acad Child Adolesc Psychiatry VL - 44 IS - 11 N2 - 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. SN - 0890-8567 UR - https://www.unboundmedicine.com/medline/citation/16239862/Long_term_effects_of_risperidone_in_children_with_autism_spectrum_disorders:_a_placebo_discontinuation_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0890-8567(09)62216-4 DB - PRIME DP - Unbound Medicine ER -