Risperidone in children with autism and serious behavioral problems

James T. McCracken, James McGough, Bhavik Shah, Pegeen Cronin, Daniel Hong, Michael G. Aman, L. Eugene Arnold, Ronald Lindsay, Patricia Nash, Jill Hollway, Christopher J. McDougle, David Posey, Naomi Swiezy, Arlene Kohn, Lawrence Scahill, Andres Martin, Kathleen Koenig, Fred Volkmar, Deirdre Carroll, Allison LancorElaine Tierney, Jaswinder Ghuman, Nilda M. Gonzalez, Marco Grados, Benedetto Vitiello, Louise Ritz, Mark Davies, James Robinson, Don McMahon

Research output: Contribution to journalArticle

1021 Citations (Scopus)

Abstract

Background: Atypical antipsychotic agents, which block postsynaptic dopamine and serotonin receptors, have advantages over traditional antipsychotic medications in the treatment of adults with schizophrenia and may be beneficial in children with autistic disorder who have serious behavioral disturbances. However, data on the safety and efficacy of atypical antipsychotic agents in children are limited. Methods: We conducted a multisite, randomized, double-blind trial of risperidone as compared with placebo for the treatment of autistic disorder accompanied by severe tantrums, aggression, or self-injurious behavior in children 5 to 17 years old. The primary outcome measures were the score on the Irritability subscale of the Aberrant Behavior Checklist and the rating on the Clinical Global Impressions - Improvement (CGI-I) scale at eight weeks. Results: A total of 101 children (82 boys and 19 girls; mean [±SD] age, 8.8±2.7 years) were randomly assigned to receive risperidone (49 children) or placebo (52). Treatment with risperidone for eight weeks (dose range, 0.5 to 3.5 mg per day) resulted in a 56.9 percent reduction in the Irritability score, as compared with a 14.1 percent decrease in the placebo group (P<0.001). The rate of a positive response, defined as at least a 25 percent decrease in the Irritability score and a rating of much improved or very much improved on the CGI-I scale, was 69 percent in the risperidone group (34 of 49 children had a positive response) and 12 percent in the placebo group (6 of 52, P<0.001). Risperidone therapy was associated with an average weight gain of 2.7±2.9 kg, as compared with 0.8±2.2 kg with placebo (P<0.001). Increased appetite, fatigue, drowsiness, dizziness, and drooling were more common in the risperidone group than in the placebo group (P< 0.05 for each comparison). In two thirds of the children with a positive response to risperidone at eight weeks (23 of 34), the benefit was maintained at six months. Conclusions: Risperidone was effective and well tolerated for the treatment of tantrums, aggression, or self-injurious behavior in children with autistic disorder. The short period of this trial limits inferences about adverse effects such as tardive dyskinesia.

Original languageEnglish (US)
Pages (from-to)314-321
Number of pages8
JournalNew England Journal of Medicine
Volume347
Issue number5
DOIs
StatePublished - Aug 1 2002

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Risperidone
Autistic Disorder
Placebos
Antipsychotic Agents
Self-Injurious Behavior
Aggression
Sialorrhea
Therapeutics
Problem Behavior
Sleep Stages
Serotonin Receptors
Dopamine Receptors
Dizziness
Appetite
Checklist
Weight Gain
Fatigue
Schizophrenia
Outcome Assessment (Health Care)
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

McCracken, J. T., McGough, J., Shah, B., Cronin, P., Hong, D., Aman, M. G., ... McMahon, D. (2002). Risperidone in children with autism and serious behavioral problems. New England Journal of Medicine, 347(5), 314-321. https://doi.org/10.1056/NEJMoa013171

Risperidone in children with autism and serious behavioral problems. / McCracken, James T.; McGough, James; Shah, Bhavik; Cronin, Pegeen; Hong, Daniel; Aman, Michael G.; Eugene Arnold, L.; Lindsay, Ronald; Nash, Patricia; Hollway, Jill; McDougle, Christopher J.; Posey, David; Swiezy, Naomi; Kohn, Arlene; Scahill, Lawrence; Martin, Andres; Koenig, Kathleen; Volkmar, Fred; Carroll, Deirdre; Lancor, Allison; Tierney, Elaine; Ghuman, Jaswinder; Gonzalez, Nilda M.; Grados, Marco; Vitiello, Benedetto; Ritz, Louise; Davies, Mark; Robinson, James; McMahon, Don.

In: New England Journal of Medicine, Vol. 347, No. 5, 01.08.2002, p. 314-321.

Research output: Contribution to journalArticle

McCracken, JT, McGough, J, Shah, B, Cronin, P, Hong, D, Aman, MG, Eugene Arnold, L, Lindsay, R, Nash, P, Hollway, J, McDougle, CJ, Posey, D, Swiezy, N, Kohn, A, Scahill, L, Martin, A, Koenig, K, Volkmar, F, Carroll, D, Lancor, A, Tierney, E, Ghuman, J, Gonzalez, NM, Grados, M, Vitiello, B, Ritz, L, Davies, M, Robinson, J & McMahon, D 2002, 'Risperidone in children with autism and serious behavioral problems', New England Journal of Medicine, vol. 347, no. 5, pp. 314-321. https://doi.org/10.1056/NEJMoa013171
McCracken JT, McGough J, Shah B, Cronin P, Hong D, Aman MG et al. Risperidone in children with autism and serious behavioral problems. New England Journal of Medicine. 2002 Aug 1;347(5):314-321. https://doi.org/10.1056/NEJMoa013171
McCracken, James T. ; McGough, James ; Shah, Bhavik ; Cronin, Pegeen ; Hong, Daniel ; Aman, Michael G. ; Eugene Arnold, L. ; Lindsay, Ronald ; Nash, Patricia ; Hollway, Jill ; McDougle, Christopher J. ; Posey, David ; Swiezy, Naomi ; Kohn, Arlene ; Scahill, Lawrence ; Martin, Andres ; Koenig, Kathleen ; Volkmar, Fred ; Carroll, Deirdre ; Lancor, Allison ; Tierney, Elaine ; Ghuman, Jaswinder ; Gonzalez, Nilda M. ; Grados, Marco ; Vitiello, Benedetto ; Ritz, Louise ; Davies, Mark ; Robinson, James ; McMahon, Don. / Risperidone in children with autism and serious behavioral problems. In: New England Journal of Medicine. 2002 ; Vol. 347, No. 5. pp. 314-321.
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T1 - Risperidone in children with autism and serious behavioral problems

AU - McCracken, James T.

AU - McGough, James

AU - Shah, Bhavik

AU - Cronin, Pegeen

AU - Hong, Daniel

AU - Aman, Michael G.

AU - Eugene Arnold, L.

AU - Lindsay, Ronald

AU - Nash, Patricia

AU - Hollway, Jill

AU - McDougle, Christopher J.

AU - Posey, David

AU - Swiezy, Naomi

AU - Kohn, Arlene

AU - Scahill, Lawrence

AU - Martin, Andres

AU - Koenig, Kathleen

AU - Volkmar, Fred

AU - Carroll, Deirdre

AU - Lancor, Allison

AU - Tierney, Elaine

AU - Ghuman, Jaswinder

AU - Gonzalez, Nilda M.

AU - Grados, Marco

AU - Vitiello, Benedetto

AU - Ritz, Louise

AU - Davies, Mark

AU - Robinson, James

AU - McMahon, Don

PY - 2002/8/1

Y1 - 2002/8/1

N2 - Background: Atypical antipsychotic agents, which block postsynaptic dopamine and serotonin receptors, have advantages over traditional antipsychotic medications in the treatment of adults with schizophrenia and may be beneficial in children with autistic disorder who have serious behavioral disturbances. However, data on the safety and efficacy of atypical antipsychotic agents in children are limited. Methods: We conducted a multisite, randomized, double-blind trial of risperidone as compared with placebo for the treatment of autistic disorder accompanied by severe tantrums, aggression, or self-injurious behavior in children 5 to 17 years old. The primary outcome measures were the score on the Irritability subscale of the Aberrant Behavior Checklist and the rating on the Clinical Global Impressions - Improvement (CGI-I) scale at eight weeks. Results: A total of 101 children (82 boys and 19 girls; mean [±SD] age, 8.8±2.7 years) were randomly assigned to receive risperidone (49 children) or placebo (52). Treatment with risperidone for eight weeks (dose range, 0.5 to 3.5 mg per day) resulted in a 56.9 percent reduction in the Irritability score, as compared with a 14.1 percent decrease in the placebo group (P<0.001). The rate of a positive response, defined as at least a 25 percent decrease in the Irritability score and a rating of much improved or very much improved on the CGI-I scale, was 69 percent in the risperidone group (34 of 49 children had a positive response) and 12 percent in the placebo group (6 of 52, P<0.001). Risperidone therapy was associated with an average weight gain of 2.7±2.9 kg, as compared with 0.8±2.2 kg with placebo (P<0.001). Increased appetite, fatigue, drowsiness, dizziness, and drooling were more common in the risperidone group than in the placebo group (P< 0.05 for each comparison). In two thirds of the children with a positive response to risperidone at eight weeks (23 of 34), the benefit was maintained at six months. Conclusions: Risperidone was effective and well tolerated for the treatment of tantrums, aggression, or self-injurious behavior in children with autistic disorder. The short period of this trial limits inferences about adverse effects such as tardive dyskinesia.

AB - Background: Atypical antipsychotic agents, which block postsynaptic dopamine and serotonin receptors, have advantages over traditional antipsychotic medications in the treatment of adults with schizophrenia and may be beneficial in children with autistic disorder who have serious behavioral disturbances. However, data on the safety and efficacy of atypical antipsychotic agents in children are limited. Methods: We conducted a multisite, randomized, double-blind trial of risperidone as compared with placebo for the treatment of autistic disorder accompanied by severe tantrums, aggression, or self-injurious behavior in children 5 to 17 years old. The primary outcome measures were the score on the Irritability subscale of the Aberrant Behavior Checklist and the rating on the Clinical Global Impressions - Improvement (CGI-I) scale at eight weeks. Results: A total of 101 children (82 boys and 19 girls; mean [±SD] age, 8.8±2.7 years) were randomly assigned to receive risperidone (49 children) or placebo (52). Treatment with risperidone for eight weeks (dose range, 0.5 to 3.5 mg per day) resulted in a 56.9 percent reduction in the Irritability score, as compared with a 14.1 percent decrease in the placebo group (P<0.001). The rate of a positive response, defined as at least a 25 percent decrease in the Irritability score and a rating of much improved or very much improved on the CGI-I scale, was 69 percent in the risperidone group (34 of 49 children had a positive response) and 12 percent in the placebo group (6 of 52, P<0.001). Risperidone therapy was associated with an average weight gain of 2.7±2.9 kg, as compared with 0.8±2.2 kg with placebo (P<0.001). Increased appetite, fatigue, drowsiness, dizziness, and drooling were more common in the risperidone group than in the placebo group (P< 0.05 for each comparison). In two thirds of the children with a positive response to risperidone at eight weeks (23 of 34), the benefit was maintained at six months. Conclusions: Risperidone was effective and well tolerated for the treatment of tantrums, aggression, or self-injurious behavior in children with autistic disorder. The short period of this trial limits inferences about adverse effects such as tardive dyskinesia.

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