Extended Management and Measurement of Autism

Exclusion Criteria

• •1. Patients who experienced a serious adverse event during the double-blind SOFIA Study which was determined to be related to the study medication by the Investigator or the sponsor
• •2. Patients who were unable to tolerate the lowest dose of study medication in the double-blind SOFIA study (2mg fluoxetine or placebo) should not be enrolled in this study
• •3. Diagnosis of Rett Syndrome, Childhood Disintegrative Disorder
• •4. Patients currently taking psychotropic medication are excluded. Patients can be enrolled in the study if the psychotropic medication has been completely withdrawn prior to the baseline visit; for at least two weeks for neuroleptics / atypical antipsychotics and for at least 5 days for stimulants
• •5. Patients exhibiting high levels of aggression, irritability or self injurious behavior to the extent that in the Investigator's opinion the patient would be more appropriately treated with psychotropic medication other than fluoxetine such as an atypical antipsychotic
• •6. Patients currently taking a monoamine oxidase inhibitor. Patients who have stopped taking an irreversible MAOI should be free of medication for at least 2 weeks prior to the baseline visit and medication free for at least one day after stopping a reversible MAOI A.
• •7. Patients with diabetes who are treated with insulin
• •8. Patients currently taking tramadol, triptans (e.g.sumatriptan), lithium, tryptophan, haloperidol, clozapine, flecainide or encainide, vinblastine, carbamazepine, tricyclic antidepressants, phenytoin or warfarin are also excluded from the study.
• •9. Current treatment with the herbal remedy, St John's Wort (Hypericum perforatum)
• •10. History of, or current cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication.
• •11. History of, or current cerebrovascular disease or brain trauma.
• •12. History of, or current significant endocrine disorder, e.g. hypo or hyperthyroidism.
• •13. History of or current malignancy.
• •14. Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as assessed by the Investigator.
• •15. Judged clinically to be at risk of suicide (suicidal ideation, severe depression, or other factors), as assessed by the Investigator.
• •16. Current active seizure disorder
• •17. Tourette's Disorder.
• •18. Female patients who are either pregnant or nursing.
• •19. Documented history of hypersensitivity or intolerance to SSRIs
• •20. Current drug abuse or dependence disorder or dependency in the 3 months prior to the baseline visit.
• •21. Clinically significant abnormalities in safety laboratory tests or vital signs as measured at baseline (as applicable) that would put the patient at substantially increased risk from study medication