Randomized Study of Fluoxetine in Children and Adolescents With Autism

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Meets diagnostic criteria for autism --Prior/Concurrent Therapy-- Other: * At least 3 months since prior electroconvulsive therapy * At least 1 month since prior investigational drugs or treatment with any drug known to cause major organ toxicity * At least 2 weeks since prior monoamine oxidase inhibitors * At least 6 weeks since prior long acting phenothiazines * At least 1 week since prior other psychotropic drugs * No prior fluoxetine of 20 mg/day for 6 weeks * At least 6 weeks since prior fluoxetine * No concurrent use of terfenadine (Seldane) or astemizole (Hismanal) * No concurrent electroconvulsive therapy or other psychotropic drugs (unless otherwise permitted) * Prior participation in another serotonin reuptake inhibitor trial allowed --Patient Characteristics-- Hematopoietic: No significant hematopoietic disease Hepatic: No prior or concurrent liver disease Renal: No prior or concurrent kidney disease Cardiovascular: * No significant cardiovascular disease * No abnormal EKG Neurological: * No prior seizure disorder or high risk development of seizures * No prior cerebrovascular disease * No prior brain trauma Other: * Not pregnant or nursing * Negative pregnancy test * No unstable major medical illness or systemic disease * No moderate or severe mental retardation and motor deficits (IQ less than 50) * No family history of bipolar disorder * No prior or concurrent other mental disorders (e.g., schizophrenia, schizoaffective, organic, or bipolar disorders) * No significant autoaggressive behavior or serious suicidal risk * No prior or concurrent gastrointestinal conditions * No unstable endocrine disease (e.g., hypo or hyperthyroidism) * No prior or concurrent malignancy * Must be able to tolerate tapering of psychoactive medication * No history of hypersensitivity or severe side effects to fluoxetine or other serotonin reuptake inhibitors * No history of severe personality disorder or noncompliance