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Citalopram Ineffective in Children With Autism

Bryan H. King, MD; Eric Hollander, MD; Linmarie Sikich, MD; James T. McCracken, MD; Lawrence Scahill, MSN, PhD; Joel D. Bregman, MD; Craig L. Donnelly, MD; Evdokia Anagnostou, MD; Kimberly Dukes, PhD; Lisa Sullivan, PhD; Deborah Hirtz, MD; Ann Wagner, PhD; Louise Ritz, MBA; for the STAART Psychopharmacology Network

Arch Gen Psychiatry. 2009;66(6):583-590.

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 Affiliations: Department of Psychiatry, Seattle Children's Hospital, University of Washington (Dr King); Department of Psychiatry, Mount Sinai School of Medicine, New York (Drs Hollander and Anagnostou), and Department of Psychiatry, North Shore–Long Island Jewish Health System, Great Neck (Dr Bregman), New York; Department of Psychiatry, University of North Carolina at Chapel Hill (Dr Sikich); Department of Psychiatry, UCLA Semel Institute, University of California at Los Angeles (Dr McCracken); Child Study Center and School of Nursing, Yale University, New Haven, Connecticut (Dr Scahill); Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire (Dr Donnelly); DM-STAT, Inc, Malden and Department of Biostatistics, Boston University, Boston (Drs Dukes and Sullivan), Massachusetts; and Office of Clinical Research, National Institute of Neurological Disorders and Stroke, Bethesda (Dr Hirtz), and Division of Developmental Translational Research, National Institute of Mental Health, Rockville (Dr Wagner and Ms Ritz), Maryland. Dr Hollander is now with the Institute of Clinical Neuroscience, New York, New York; Dr Anagnostou is now with the Bloorview Research Institute and the Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada; and Ms Ritz is now with the Office of Clinical Research, National Institute of Neurological Disorders and Stroke, Bethesda, Maryland.

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