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Risperidone improves restricted, repetitive, and stereotyped behaviour in autistic children and adolescents BMJ Publishing Group Ltd, Royal College of Psychiatrists and British Psychological Society Evid Based Mental Health 2006 9: 6
doi: 10.1136/ebmh.9.1.6
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THERAPEUTICS
6
Risperidone improves restricted, repetitive, and stereotyped behaviour in autistic children and adolescents McDougle CJ, Hollway J, Scahill L, et al. Risperidone for the core symptom domains of autism: results from the study by the autism network of the research units on pediatric psychopharmacology. Am J Psychiatry 2005;162:1142–8.
This article contains extra text on the EBMH website
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risperidone improve repetitive behaviour and social and communication impairment in children and adolescents Q Does with autism? CONCLUSIONS
METHODS Design: Randomised controlled trial.
Risperidone improves restricted, repetitive, and stereotyped patterns of behaviour, interests, and activities but not social interaction and communication in autistic children and adolescents
Allocation: Not stated.
Blinding: Double blind.
Follow up period: Eight weeks.
Setting: Five universities, USA; time period not stated.
Patients: 101 children and adolescents aged 12–17 years with autism and impairing behavioural symptoms (DSM-IV, Autism Diagnostic Interview (revised); mean age 8.8 years; 82% male). Exclusions: not stated.
Intervention: Risperidone (0.5 to 3.5 mg/day); placebo.
Outcomes: Symptomatic behaviours (modified parent rated Ritvo-Freeman Real Life Scale (RFRLS), higher score indicates greater symptom severity).
Patient follow up: Not stated.
MAIN RESULTS At eight weeks, risperidone improved overall symptomatic behaviours compared with placebo (change in overall RFRLS score from baseline to eight weeks risperidone v placebo: 20.49 v 20.15; Cohen’s effect size 1.08; p,0.001). Analysis of the individual subscales of the RFRLS suggested that risperidone improved sensory motor behaviours, affectual reactions, sensory responses, and obsessive-compulsive symptom severity, but not social relatedness or communication (see http://www.ebmentalhealth.com/supplemental for table). ............................................................. For correspondence: Dr C J McDougle, Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN 46202-4800, USA;
[email protected] Sources of funding: National Institute of Health, USA.
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Commentary
T
his article extends the analysis of an eight week double blind placebo controlled trial of risperidone in children and adolescents with autism,1 and of the 16 week open label continuation phase. The secondary outcome measures of the randomised controlled trial (RCT) were used to assess whether risperidone (1.8 mg/d in the RCT phase; 2.1 mg at the end of the open label phase) was also efficacious in reducing core symptoms of the three domains which define autism. In order to assess change in symptom domains, the authors relied on the Ritvo-Freeman Real Life Scale (RFRLS), the Children’s Yale-Brown Obsessive Compulsive Scale (Y-BOCS), and the Maladaptive Behavior Domain of Vineland Adaptive Behavior Scales. Substantial changes were made in the wording, content, and mode of administration of these measures. A significant reduction was obtained on the RFRLS subscales, which assess sensory motor behaviours and responses and affect reactions, but no significant change was attained in the social relationship and language subscales of this instrument. Significant improvements were also obtained with the compulsion scores of the Y-BOCS. In both cases, improvements were maintained over the 16 week open label continuation. Results were similar for the Vineland maladaptive behaviours. The authors concluded that risperidone was efficacious in improving the restricted, repetitive, and stereotyped patterns of behaviours but that no significant change was obtained in the core domains of social interactions and language/communication in autism. This study consolidates the results of an important RCT in showing the beneficial effects of relatively small doses of risperidone in autism. Although the effects were confined to non-specific behavioural problems and restricted and repetitive autistic behaviours, the effect sizes for the social relationship and the language outcome measures were actually higher than those obtained with other subscales, and an inspection of the data suggests that floor effects on the social and language scores may explain the lack of statistical significance. Better measures to evaluate change in drug studies are needed for autism research. Eric Fombonne, MD Montreal Children’s Hospital, Montreal, Canada
1 McCracken JT, McGough J, Shah B, et al. Risperidone in children with autism and serious behavioral problems. N Engl J Med 2002;347:314–21.
EBMH Volume 9 February 2006
