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| Research article summary (published 30 May 2009): |
Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior: citalopram ineffective in children with autism.
Full Abstract
CONTEXT: Selective serotonin reuptake inhibitors are widely prescribed for children with autism spectrum disorders. OBJECTIVES: To determine the efficacy and safety of citalopram hydrobromide therapy for repetitive behavior in children with autism spectrum disorders. DESIGN: National Institutes of Health-sponsored randomized controlled trial. SETTING: Six academic centers, including Mount Sinai School of Medicine, North Shore-Long Island Jewish Health System, University of North Carolina at Chapel Hill, University of California at Los Angeles, Yale University, and Dartmouth Medical School. PARTICIPANTS: One hundred forty-nine volunteers 5 to 17 years old (mean [SD] age, 9.4 [3.1] years) were randomized to receive citalopram (n = 73) or placebo (n = 76). Participants had autistic spectrum disorders, Asperger disorder, or pervasive developmental disorder, not otherwise specified; had illness severity ratings of at least moderate on the Clinical Global Impressions, Severity of Illness Scale; and scored at least moderate on compulsive behaviors measured with the Children's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders. INTERVENTIONS: Twelve weeks of citalopram hydrobromide (10 mg/5 mL) or placebo. The mean (SD) maximum dosage of citalopram hydrobromide was 16.5 (6.5) mg/d by mouth (maximum, 20 mg/d). MAIN OUTCOME MEASURES: Positive response was defined by a score of much improved or very much improved on the Clinical Global Impressions, Improvement subscale. An important secondary outcome was the score on the Children's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders. Adverse events were systematically elicited using the Safety Monitoring Uniform Report Form. RESULTS: There was no significant difference in the rate of positive response on the Clinical Global Impressions, Improvement subscale between the citalopram-treated group (32.9%) and the placebo group (34.2%) (relative risk, 0.96; 95% confidence interval, 0.61-1.51; P > .99). There was no difference in score reduction on the Children's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders from baseline (mean [SD], -2.0 [3.4] points for the citalopram-treated group and -1.9 [2.5] points for the placebo group; P = .81). Citalopram use was significantly more likely to be associated with adverse events, particularly increased energy level, impulsiveness, decreased concentration, hyperactivity, stereotypy, diarrhea, insomnia, and dry skin or pruritus. CONCLUSION: Results of this trial do not support the use of citalopram for the treatment of repetitive behavior in children and adolescents with autism spectrum disorders. Trial Registration clinicaltrials.gov Identifier: NCT00086645.
Author information
Author/s: King, Bryan H (BH); Hollander, Eric (E); Sikich, Linmarie (L); McCracken, James T (JT); Scahill, Lawrence (L); Bregman, Joel D (JD); Donnelly, Craig L (CL); Anagnostou, Evdokia (E); Dukes, Kimberly (K); Sullivan, Lisa (L); Hirtz, Deborah (D); Wagner, Ann (A); Ritz, Louise (L); STAART Psychopharmacology Network;
Affiliation: Seattle Children's Hospital, University of Washington, 4800 Sand Point Way NE, Seattle, WA 98105, USA. bhking(-atsign-)u.washington.edu
Grants: U01-HD045023 (Agency:NICHD NIH HHS) ; U54-MH066398 (Agency:NIMH NIH HHS) ; U54-MH066494 (Agency:NIMH NIH HHS) ; U54-MH066673 (Agency:NIMH NIH HHS) ; U54-MH068172 (Agency:NIMH NIH HHS)
Journal and publication information
Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural
Journal: Archives of general psychiatry (Arch Gen Psychiatry), published in United States. (Language: eng)
Reference: 2009-Jun; vol 66 (issue 6) : pp 583-90
Dates: Created 2009/06/02; Completed 2009/06/09;
PMID: 19487623, status: MEDLINE (last retrieval date: 6/9/2009, IMS Date: 09 Jun 2009 00:00:00)
Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.
Comments and Corrections
CommentIn: Arch Gen Psychiatry. 2009 Jun;66(6):581-2. (PMID: 19487622)
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