TY - JOUR
T1 - Risperidone in children with disruptive behavior disorders and subaverage intelligence
T2 - A 1-year, open-label study of 504 patients
AU - Croonenberghs, Jan
AU - Fegert, Joerg M.
AU - Findling, Robert L.
AU - De Smedt, Goedele
AU - Van Dongen, Stefan
N1 - Funding Information:
This research was supported by Johnson & Johnson Pharmaceutical Research and Development, Beerse, Belgium. The authors thank Sigrid Versele, Alain Schotte, Shulamit Gelerstein, Willem Kriel, Ben Lyons, Ilse Van Hove, and Philippe Lechat for their valuable contribution in conducting the trial and analyzing the data. The authors also thank the members of the Risperidone Disruptive Behavior Study Group for their skilled participation in this year-long study.
PY - 2005/1
Y1 - 2005/1
N2 - Objective: To determine the long-term safety and effectiveness of risperidone for severe disruptive behaviors in children. Method: A multisite, 1-year, open-label study of patients aged 5 to 14 years with disruptive behaviors and subaverage intelligence was conducted. Results: Seventy-three percent of the 504 patients enrolled completed the study. The mean ± SE dose of risperidone was 1.6 ± 0.0 mg/day. The most common adverse events were somnolence (30%), rhinitis (27%), and headache (22%). The incidence of movement disorders was low, and mean Extrapyramidal Symptom Rating Scale scores decreased during risperidone treatment. No clinically significant changes in mean laboratory values were noted, except for a transient increase in serum prolactin levels. Scores on the Nisonger Child Behavior Rating Form Conduct Problem Scale improved significantly as early as week 1, and improvement was maintained throughout the trial (p < .001 at each time point). Significant improvements were noted on positive social behavior and other Nisonger Child Behavior Rating Form subscales, Aberrant Behavior Checklist, Clinical Global Impressions scale, and tests of patients' cognitive function (each p < .001). Conclusions: Risperidone was well tolerated and effective in the long-term treatment of disruptive behavior disorders in children with subaverage intelligence.
AB - Objective: To determine the long-term safety and effectiveness of risperidone for severe disruptive behaviors in children. Method: A multisite, 1-year, open-label study of patients aged 5 to 14 years with disruptive behaviors and subaverage intelligence was conducted. Results: Seventy-three percent of the 504 patients enrolled completed the study. The mean ± SE dose of risperidone was 1.6 ± 0.0 mg/day. The most common adverse events were somnolence (30%), rhinitis (27%), and headache (22%). The incidence of movement disorders was low, and mean Extrapyramidal Symptom Rating Scale scores decreased during risperidone treatment. No clinically significant changes in mean laboratory values were noted, except for a transient increase in serum prolactin levels. Scores on the Nisonger Child Behavior Rating Form Conduct Problem Scale improved significantly as early as week 1, and improvement was maintained throughout the trial (p < .001 at each time point). Significant improvements were noted on positive social behavior and other Nisonger Child Behavior Rating Form subscales, Aberrant Behavior Checklist, Clinical Global Impressions scale, and tests of patients' cognitive function (each p < .001). Conclusions: Risperidone was well tolerated and effective in the long-term treatment of disruptive behavior disorders in children with subaverage intelligence.
KW - Child and youth psychopharmacology
KW - Disruptive behavior disorder
KW - Risperidone
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U2 - 10.1097/01.chi.0000145805.24274.09
DO - 10.1097/01.chi.0000145805.24274.09
M3 - Article
C2 - 15608545
AN - SCOPUS:10944267641
SN - 0890-8567
VL - 44
SP - 64
EP - 72
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
IS - 1
ER -