Randomized Study of Fluoxetine in Children and Adolescents With Autism

Study start date: September 1, 1998

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