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Double-blind, placebo-controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence.
Am J Psychiatry. 2002 Aug; 159(8):1337-46.AJ

Abstract

OBJECTIVE

The short-term efficacy and safety of risperidone in the treatment of disruptive behaviors was examined in a well-characterized cohort of children with subaverage intelligence.

METHOD

In this 6-week, multicenter, double-blind, parallel-group study of 118 children (aged 5-12 years) with severely disruptive behaviors and subaverage intelligence (IQ between 36 and 84, inclusive), the subjects received 0.02-0.06 mg/kg per day of risperidone oral solution or placebo. The a priori primary efficacy measure was the change in score from baseline to endpoint on the conduct problem subscale of the Nisonger Child Behavior Rating Form.

RESULTS

The risperidone group showed significantly greater improvement than did the placebo group on the conduct problem subscale of the Nisonger Child Behavior Rating Form from week 1 through endpoint (change in score of -15.2 and -6.2, respectively). Risperidone was also associated with significantly greater improvement than placebo on all other Nisonger Child Behavior Rating Form subscales at endpoint, as well as on the Aberrant Behavior Checklist subscales for irritability, lethargy/social withdrawal, and hyperactivity; the Behavior Problems Inventory aggressive/destructive behavior subscale; a visual analogue scale of the most troublesome symptom; and the Clinical Global Impression change score. The most common adverse effects reported during risperidone treatment were headache and somnolence. The extrapyramidal symptom profile of risperidone was comparable to that of placebo. Mean weight increases of 2.2 kg. and 0.9 kg occurred in the risperidone and placebo groups, respectively.

CONCLUSIONS

Risperidone was effective and well tolerated for the treatment of severely disruptive behaviors in children with subaverage IQ.

Authors+Show Affiliations

Nisonger Center UAP, Ohio State University, Columbus 43210-1257, USA. aman.1@osu.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

12153826

Citation

Aman, Michael G., et al. "Double-blind, Placebo-controlled Study of Risperidone for the Treatment of Disruptive Behaviors in Children With Subaverage Intelligence." The American Journal of Psychiatry, vol. 159, no. 8, 2002, pp. 1337-46.
Aman MG, De Smedt G, Derivan A, et al. Double-blind, placebo-controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence. Am J Psychiatry. 2002;159(8):1337-46.
Aman, M. G., De Smedt, G., Derivan, A., Lyons, B., & Findling, R. L. (2002). Double-blind, placebo-controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence. The American Journal of Psychiatry, 159(8), 1337-46.
Aman MG, et al. Double-blind, Placebo-controlled Study of Risperidone for the Treatment of Disruptive Behaviors in Children With Subaverage Intelligence. Am J Psychiatry. 2002;159(8):1337-46. PubMed PMID: 12153826.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Double-blind, placebo-controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence. AU - Aman,Michael G, AU - De Smedt,Goedele, AU - Derivan,Albert, AU - Lyons,Ben, AU - Findling,Robert L, AU - ,, PY - 2002/8/3/pubmed PY - 2002/8/28/medline PY - 2002/8/3/entrez SP - 1337 EP - 46 JF - The American journal of psychiatry JO - Am J Psychiatry VL - 159 IS - 8 N2 - OBJECTIVE: The short-term efficacy and safety of risperidone in the treatment of disruptive behaviors was examined in a well-characterized cohort of children with subaverage intelligence. METHOD: In this 6-week, multicenter, double-blind, parallel-group study of 118 children (aged 5-12 years) with severely disruptive behaviors and subaverage intelligence (IQ between 36 and 84, inclusive), the subjects received 0.02-0.06 mg/kg per day of risperidone oral solution or placebo. The a priori primary efficacy measure was the change in score from baseline to endpoint on the conduct problem subscale of the Nisonger Child Behavior Rating Form. RESULTS: The risperidone group showed significantly greater improvement than did the placebo group on the conduct problem subscale of the Nisonger Child Behavior Rating Form from week 1 through endpoint (change in score of -15.2 and -6.2, respectively). Risperidone was also associated with significantly greater improvement than placebo on all other Nisonger Child Behavior Rating Form subscales at endpoint, as well as on the Aberrant Behavior Checklist subscales for irritability, lethargy/social withdrawal, and hyperactivity; the Behavior Problems Inventory aggressive/destructive behavior subscale; a visual analogue scale of the most troublesome symptom; and the Clinical Global Impression change score. The most common adverse effects reported during risperidone treatment were headache and somnolence. The extrapyramidal symptom profile of risperidone was comparable to that of placebo. Mean weight increases of 2.2 kg. and 0.9 kg occurred in the risperidone and placebo groups, respectively. CONCLUSIONS: Risperidone was effective and well tolerated for the treatment of severely disruptive behaviors in children with subaverage IQ. SN - 0002-953X UR - https://www.unboundmedicine.com/medline/citation/12153826/Double_blind_placebo_controlled_study_of_risperidone_for_the_treatment_of_disruptive_behaviors_in_children_with_subaverage_intelligence_ L2 - https://ajp.psychiatryonline.org/doi/10.1176/appi.ajp.159.8.1337?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -