Study of Fluoxetine in Adults With Autistic Disorder

Exclusion Criteria

• •Pregnant or nursing
• •Prior or concurrent history of mental disorders, including schizophrenia, schizoaffective disorder, organic mental disorders, or bipolar disorders
• •Concurrent depression determined by DSM-IV diagnosis
• •Serious suicidal risk
• •Active seizure disorder within the past 2 years
• •Clinically significant or unstable medical illness, including hematopoietic or cardiovascular disease
• •Any organic or systemic disease
• •Any geographical condition that would preclude study compliance
• •Prior or concurrent gastrointestinal, liver, or kidney disease
• •Any other concurrent condition that interferes with the absorption, distribution, metabolism, or excretion of drugs
• •Prior or concurrent cerebrovascular disease or brain trauma
• •Prior or concurrent clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism
• •Prior or concurrent malignancy
• •Clinically significant abnormalities on EKG, laboratory tests, or physical exam
• •Requirement for ECT or any other psychotropic medication
• •Inability to tolerate taper from psychoactive medication
• •History of hypersensitivity or severe side effects associated with the use of fluoxitine or other serotonin reuptake inhibitors
• •Treatment with any drug known to have a well-defined potential for toxicity to a major organ within the past 30 days
• •Concurrent terfenadine (Seldane) or astemizole (Hismanal)
• •Prior treatment with fluoxetine of 40 mg/day for 6 weeks
• •Prior electroconvulsive therapy within the past 3 months
• •Prior investigational drug use within the past 30 days
• •Prior Monoamine oxidase inhibitor use within the past 14 days
• •Prior long-acting phenothiazines within the past 6 weeks
• •Prior psychotropic drugs within the past 7 days
• •Prior fluoxetine within the past 6 weeks
• •Requirement for any therapeutic intervention that would confound study evaluation