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Cited by 161Schizophrenia research and treatmentChild and Adolescent Psychosocial and Emotional DevelopmentAttention Deficit Hyperactivity Disorder

Long-Term, Open-Label Study of Risperidone in Children With Severe Disruptive Behaviors and Below-Average IQ

Findling, Robert L., Aman, Michael G., Eerdekens, Marielle, Derivan, Albert, Lyons, Ben, The Risperidone Disruptive Behavior Study Group·2004·American Journal of Psychiatry
DOI 10.1176/appi.ajp.161.4.677
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Abstract

OBJECTIVE: This study determined the long-term safety and effectiveness of risperidone in treating severe disruptive behavior in children with subaverage intelligence. METHOD: This 48-week, open-label extension included 107 children ages 5-12 years with severe disruptive behavior disorders (according to DSM-IV criteria and a score of > or = 24 on the conduct problem subscale of the Nisonger Child Behavior Rating Form) and subaverage intelligence (IQ 36-84) who completed at least 2 weeks of a randomized, double-blind, placebo-controlled study of risperidone. All patients received 0.02-0.06 mg/kg/day of oral risperidone; the purpose was to accumulate long-term safety data. Scores on the Nisonger Child Behavior Rating Form were also obtained. RESULTS: The mean risperidone dose was 1.5 mg/day. The most common adverse events reported were somnolence (33%), headache (33%), rhinitis (28%), and weight gain (21%). Somnolence was usually mild and transient. The mean weight increase was 5.5 kg; half was attributable to developmentally expected growth. Transient and asymptomatic increases in prolactin levels were observed. There were no significant changes in Extrapyramidal Symptom Rating Scale scores and no cases of tardive dyskinesia. No clinically relevant changes in ECGs or vital signs were noted. Risperidone was associated with rapid, significant improvement on the conduct problem subscale score of the Nisonger Child Behavior Rating Form in patients previously treated with placebo; improvement was maintained during long-term treatment and in patients previously given risperidone. CONCLUSIONS: Long-term risperidone appears to be generally safe, well tolerated, and effective for treating severely disruptive behaviors in children with subaverage intelligence.

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Authors
Findling, R. L., Aman, M. G., Eerdekens, M., Derivan, A., Lyons, B., & The Risperidone Disruptive Behavior Study Group
Affiliations
University Hospitals of Cleveland (US)
ORCID
Findling, Robert L.
Venue
American Journal of Psychiatry
Publisher
American Psychiatric Association Publishing
Published
2004-04
Volume
161
Issue
4
Pages
677-684
ISSN
  • 0002-953X (ISSN-L)
  • 1535-7228
DOI
10.1176/appi.ajp.161.4.677
OpenAlex
W2167767364
Cited by
161
References
30
Citations by year
2026: 2 · 2025: 2 · 2024: 6 · 2023: 3 · 2022: 4 · 2020: 2 · 2019: 4 · 2018: 4 · 2017: 6 · 2016: 3 · 2015: 5 · 2014: 4 · 2013: 6 · 2012: 7
FWCI
12.56
Type
journal article
Language
en
Open access
closed
Locations
  • American Journal of Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Social Sciences › Psychology › Clinical Psychology › Child and Adolescent Psychosocial and Emotional Development
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
Keywords
risperidone, disruptive behavior disorders, conduct problems, intellectual disability, children, long-term safety, adverse events, sleepiness, weight gain, prolactin, extrapyramidal symptoms, tardive dyskinesia, antipsychotic drugs
MeSH terms
Child, Child, Preschool, Cognition Disorders, Double-Blind Method, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Intelligence, Male, Antipsychotic Agents, Risperidone, Attention Deficit and Disruptive Behavior Disorders, Diagnostic and Statistical Manual of Mental Disorders

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