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Risperidone treatment of autistic disorder: longer-term benefits and blinded discontinuation after 6 months.
Am J Psychiatry. 2005 Jul; 162(7):1361-9.AJ

Abstract

OBJECTIVE

Risperidone is effective for short-term treatment of aggression, temper outbursts, and self-injurious behavior in children with autism. Because these behaviors may be chronic, there is a need to establish the efficacy and safety of longer-term treatment with this agent.

METHOD

The authors conducted a multisite, two-part study of risperidone in children ages 5 to 17 years with autism accompanied by severe tantrums, aggression, and/or self-injurious behavior who showed a positive response in an earlier 8-week trial. Part I consisted of 4-month open-label treatment with risperidone, starting at the established optimal dose; part II was an 8-week randomized, double-blind, placebo-substitution study of risperidone withdrawal. Primary outcome measures were the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression improvement scale.

RESULTS

Part I included 63 children. The mean risperidone dose was 1.96 mg/day at entry and remained stable over 16 weeks of open treatment. The change on the Aberrant Behavior Checklist irritability subscale was small and clinically insignificant. Reasons for discontinuation of part I included loss of efficacy (N=5) and adverse effects (N=1). The subjects gained an average of 5.1 kg. Part II included 32 patients. The relapse rates were 62.5% for gradual placebo substitution and 12.5% for continued risperidone; this difference was statistically significant.

CONCLUSIONS

Risperidone showed persistent efficacy and good tolerability for intermediate-length treatment of children with autism characterized by tantrums, aggression, and/or self-injurious behavior. Discontinuation after 6 months was associated with a rapid return of disruptive and aggressive behavior in most subjects.

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

15994720

Citation

Research Units on Pediatric Psychopharmacology Autism Network. "Risperidone Treatment of Autistic Disorder: Longer-term Benefits and Blinded Discontinuation After 6 Months." The American Journal of Psychiatry, vol. 162, no. 7, 2005, pp. 1361-9.
Research Units on Pediatric Psychopharmacology Autism Network. Risperidone treatment of autistic disorder: longer-term benefits and blinded discontinuation after 6 months. Am J Psychiatry. 2005;162(7):1361-9.
Research Units on Pediatric Psychopharmacology Autism Network. (2005). Risperidone treatment of autistic disorder: longer-term benefits and blinded discontinuation after 6 months. The American Journal of Psychiatry, 162(7), 1361-9.
Research Units on Pediatric Psychopharmacology Autism Network. Risperidone Treatment of Autistic Disorder: Longer-term Benefits and Blinded Discontinuation After 6 Months. Am J Psychiatry. 2005;162(7):1361-9. PubMed PMID: 15994720.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risperidone treatment of autistic disorder: longer-term benefits and blinded discontinuation after 6 months. A1 - ,, PY - 2005/7/5/pubmed PY - 2005/8/18/medline PY - 2005/7/5/entrez SP - 1361 EP - 9 JF - The American journal of psychiatry JO - Am J Psychiatry VL - 162 IS - 7 N2 - OBJECTIVE: Risperidone is effective for short-term treatment of aggression, temper outbursts, and self-injurious behavior in children with autism. Because these behaviors may be chronic, there is a need to establish the efficacy and safety of longer-term treatment with this agent. METHOD: The authors conducted a multisite, two-part study of risperidone in children ages 5 to 17 years with autism accompanied by severe tantrums, aggression, and/or self-injurious behavior who showed a positive response in an earlier 8-week trial. Part I consisted of 4-month open-label treatment with risperidone, starting at the established optimal dose; part II was an 8-week randomized, double-blind, placebo-substitution study of risperidone withdrawal. Primary outcome measures were the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression improvement scale. RESULTS: Part I included 63 children. The mean risperidone dose was 1.96 mg/day at entry and remained stable over 16 weeks of open treatment. The change on the Aberrant Behavior Checklist irritability subscale was small and clinically insignificant. Reasons for discontinuation of part I included loss of efficacy (N=5) and adverse effects (N=1). The subjects gained an average of 5.1 kg. Part II included 32 patients. The relapse rates were 62.5% for gradual placebo substitution and 12.5% for continued risperidone; this difference was statistically significant. CONCLUSIONS: Risperidone showed persistent efficacy and good tolerability for intermediate-length treatment of children with autism characterized by tantrums, aggression, and/or self-injurious behavior. Discontinuation after 6 months was associated with a rapid return of disruptive and aggressive behavior in most subjects. SN - 0002-953X UR - https://www.unboundmedicine.com/medline/citation/15994720/Risperidone_treatment_of_autistic_disorder:_longer_term_benefits_and_blinded_discontinuation_after_6_months_ L2 - https://ajp.psychiatryonline.org/doi/full/10.1176/appi.ajp.162.7.1361?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -