A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF FLUVOXAMINE IN ADULTS WITH AUTISTIC DISORDER

Background: Autistic disorder is characterized by a fundamental distur bance in social interaction, impairments in communication, and a marke dly restricted repertoire of activities and interests. Abnormalities i n the serotonin neurotransmitter system have been identified in some p ersons with autism. No consistently effective and safe drugs have been developed for treating the symptoms of autism. Methods: Thirty adults with autistic disorder completed a 12-week double-blind, placebo-cont rolled trial of the potent and selective serotonin uptake inhibitor fl uvoxamine maleate. Behavioral ratings were obtained at baseline and af ter 4, 8, and 12 weeks of treatment. Results: Eight (53%) of 15 patien ts in the fluvoxamine-treated group were categorized as responders com pared with none of 15 in the placebo group (P=.001). Fluvoxamine was s uperior to placebo in reducing repetitive thoughts and behavior (P<.00 1), maladaptive behavior (P<.001), and aggression (P<.03), and in impr oving some aspects of social relatedness (P<.04), especially language usage (P<.008). Treatment response was not correlated with age, level of autistic behavior, or full-scale IQ. Other than mild sedation and n ausea in a few patients, fluvoxamine was well tolerated. No dyskinesia s, adverse cardiovascular events, or seizures occurred. Conclusions: F luvoxamine is more effective than placebo in the short-term treatment of the symptoms of autistic disorder in adults. Controlled studies of fluvoxamine and other potent and selective serotonin uptake inhibitors seem warranted in children and adolescents with autism.