Abstract
Subgroup analysis of children (5–12 years) with autism enrolled in an 8-week, double-blind, placebo-controlled trial of risperidone for pervasive developmental disorders. The primary efficacy measure was the Aberrant Behavior Checklist-Irritability (ABC-I) subscale. Data were available for 55 children given risperidone (n = 27) or placebo (n = 28); mean baseline ABC-I ( ± SD) was 20.6 (8.1) and 21.6 (10.2). Risperidone [mean dose ( ± SD): 1.37 mg/day (0.7)] resulted in significantly greater reduction from baseline to endpoint in ABC-I versus placebo [mean change ( ± SD): −13.4 (1.5) vs. −7.2 (1.4), P < 0.05; ES = −0.7]. The most common adverse effect with risperidone was somnolence (74% vs. 7% with placebo). Risperidone treatment was well tolerated and significantly improved behavioral problems associated with autism.
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References
Aman, M. G. (2004). Management of hyperactivity and other acting-out problems in patients with autism spectrum disorder. Seminars in Pediatric Neurology, 11, 225–228.
Aman, M. G., Novotny, S., Samango-Sprouse, C., Lecavalier, L., Leonard, E., Gadow, K. D., et al. (2004). Outcome measures for clinical drug trials in autism. CNS Spectrums, 9, 36–47.
Aman, M. G., Singh, N. N., Stewart, A. W., & Field, C. J. (1985). The aberrant behavior checklist: A behavior rating scale for the assessment of treatment effects. American Journal of Mental Deficiency, 89, 485–491.
Aman, M. G., Tassé, M. J., Rojahn, J., & Hammer, D. (1996). The Nisonger CBRF: A child behavior rating form for children with developmental disabilities. Research in Developmental Disabilities, 17, 41–57.
American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. (2004). Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care, 27, 596–601.
American Psychiatric Association. (2000). Diagnostic and statistical manual of mental disorders. Washington: American Psychiatric Press.
Arnold, L. E., Vitiello, B., McDougle, C., Scahill, L., Shah, B., Gonzalez, N. M., et al. (2003). Parent-defined target symptoms respond to risperidone in RUPP autism study: Customer approach to clinical trials. Journal of the American Academy of Child and Adolescent Psychiatry, 42, 1443–1450.
Carter, A. S., Volmar, F. R., Sparrow, S. S., Wang, J. J., Lord, C., Dawson, G., et al. (1998). The Vineland Adaptive Behavioral Scales: Supplementary norms of individuals with autism. Journal of Autism and Developmental Disorders, 28, 287–302.
Chez, M. G., Memon, S., & Hung, P. C. (2004). Neurologic treatment strategies in autism: An overview of medical intervention strategies. Seminars in Pediatric Neurology, 11, 229–235.
Chouinard, G., Ross-Chouinard, A., Annable, L., & Jones, B. D. (1980). Extrapyramidal symptom rating scale. The Canadian Journal of Neurological Sciences, 7, 233.
Dunbar, F., Kusumakar, V., Daneman, D., & Schultz, M. (2004). Growth and sexual maturation during long-term treatment with risperidone. American Journal of Psychiatry, 161, 918–920.
Findling, R., Kusumakar, V., Daneman, D., Moshang, T., De Smedt, G., & Binder, C. (2003). Prolactin levels during long-term risperidone treatment in children and adolescents. Journal of Clinical Psychiatry, 64, 1362–1369.
Fombonne, E. (2003). Epidemiological surveys of autism and other pervasive developmental disorders: An update. Journal of Autism and Developmental Disorders, 33, 365–382.
Gagliano, A., Germano, E., Pustorino, G., Impallomeni, C., D’Arrigo, C., Calamoneri, F., & Spina, E. (2004). Risperidone treatment of children with autistic disorder: Effectiveness, tolerability, and pharmacokinetic implications. Journal of Child and Adolescent Psychopharmacology, 14, 39–47.
Horner, R. H., Carr, E. G., Strain, P. S., Todd, A. W., & Reed, H. K. (2002). Problem behavior interventions for young children with autism: A research synthesis. Journal of Autism and Developmental Disorders, 32, 423–446.
Malone, R. P., Maislin, G., Choudhury, M. S., Gifford, C., & Delaney, M. A. (2002). Risperidone treatment in children and adolescents with autism: Short- and long-term safety and effectiveness. Journal of the American Academy of Child and Adolescent Psychiatry, 41, 140–147.
Masi, G. (2004). Pharmacotherapy of pervasive developmental disorders in children and adolescents. CNS Drugs, 18, 1031–1052.
Masi, G., Cosenza, A., Mucci, M., & Brovedani, P. (2003). A 3-year naturalistic study of 53 preschool children with pervasive developmental disorders treated with risperidone. The Journal of Clinical Psychiatry, 64, 1039–1047.
McCracken, J. T., McGough, J., Shah, B., Cronin, P., Hong, D., Aman, M. G., et al., Research Units on Pediatric Psychopharmacology Autism Network. (2002). Risperidone in children with autism and serious behavioral problems. The New England Journal of Medicine, 347, 314–321.
McDougle, C. J., Scahill, L., Aman, M. G., McCracken, J. T., Tierney, E., Davies, M., et al. (2005). Risperidone for the core symptom domains of autism: Results from the study by the autism network of the research units on pediatric psychopharmacology. The American Journal of Psychiatry, 162, 1142–1148.
Nicolson, R., Awad, G., & Sloman, L. (1998). An open trial of risperidone in young autistic children. Journal of the American Academy of Child and Adolescent Psychiatry, 37, 372–376.
Posey, D. J., & McDougle, C. J. (2000). The pharmacotherapy of target symptoms associated with autistic disorder and other pervasive developmental disorders. Harvard Review of Psychiatry, 8, 45–63.
Reyes, M., Buitelaar, J., Toren, P., Augustyns, I., & Eerdekens, M. (2006). A randomized, double-blind, placebo-controlled withdrawal study of risperidone in maintenance treatment of children and adolescents with disruptive behaviour disorder. American Journal of Psychiatry, 163, 402–410.
Schopler, E., Reichler, R. J., DeVellis, R. F., & Daly, K. (1980). Toward objective classification of childhood autism: Childhood Autism Rating Scale (CARS). Journal of Autism and Developmental Disorders, 10, 91–103.
Shea, S., Turgay, A., Carroll, A., Schulz, M., Orlik, H., Smith, I., & Dunbar, F. (2004). Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders. Pediatrics, 114, e634–e641.
Sparrow, S., & Cicchetti, D. (1985). Diagnostic uses of the Vineland Adaptive Behavior Scales. Journal of Pediatric Psychology, 10, 215–225.
Tassé, M. J., Aman, M. G., & Rojahn, J. (1996). The Nisonger Child Behavior Rating Form: Age and gender effects and norms. Research in Developmental Disabilities, 17, 59–75.
Yeargin-Allsopp, M., Rice, C., Karapurkar, T., Doernberg, N., Boyle, C., & Murphy, C. (2003). Prevalence of autism in a US metropolitan area. JAMA: The Journal of the American Medical Association, 289, 49–55.
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Pandina, G.J., Bossie, C.A., Youssef, E. et al. Risperidone Improves Behavioral Symptoms in Children with Autism in a Randomized, Double-Blind, Placebo-Controlled Trial. J Autism Dev Disord 37, 367–373 (2007). https://doi.org/10.1007/s10803-006-0234-7
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DOI: https://doi.org/10.1007/s10803-006-0234-7