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Christopher J. McDougle, MD; Janice P. Holmes, RN, MSN; Derek C. Carlson, MD; Gregory H. Pelton, MD; Donald J. Cohen, MD; Lawrence H. Price, MD

Arch Gen Psychiatry. 1998;55:633-641.

Background  Neurobiological research has implicated the dopamine and serotonin systems in the pathogenesis of autism. Open-label reports suggest that the serotonin_2A–dopamine D₂ antagonist risperidone may be safe and effective in reducing the interfering symptoms of patients with autism.

Methods  Thirty-one adults (age [mean+SD], 28.1±7.3 years) with autistic disorder (n=17) or pervasive developmental disorder not otherwise specified (n=14) participated in a 12-week double-blind, placebo-controlled trial of risperidone. Patients treated with placebo subsequently received a 12-week open-label trial of risperidone.

Results  For persons completing the study, 8 (57%) of 14 patients treated with risperidone were categorized as responders (daily dose [mean ± SD], 2.9±1.4 mg) compared with none of 16 in the placebo group (P<.002). Risperidone was superior to placebo in reducing repetitive behavior (P<.001), aggression (P<.001), anxiety or nervousness (P<.02), depression (P<.03), irritability (P<.01), and the overall behavioral symptoms of autism (P<.02). Objective, measurable change in social behavior and language did not occur. Nine (60%) of 15 patients who received treatment with open-label risperidone following the double-blind placebo phase responded. Other than mild, transient sedation, risperidone was well tolerated, with no evidence of extrapyramidal effects, cardiac events, or seizures.

Conclusion  Risperidone is more effective than placebo in the short-term treatment of symptoms of autism in adults.

From the Department of Psychiatry, Section of Child and Adolescent Psychiatry, Indiana University School of Medicine, Indianapolis (Dr McDougle); the Department of Psychiatry (Ms Holmes and Drs Carlson and Cohen) and the Child Study Center (Dr Cohen), Yale University School of Medicine, New Haven, Conn; the Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, NY (Dr Pelton); and the Department of Psychiatry and Human Behavior, Brown University School of Medicine, Providence, RI (Dr Price).

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