Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder

Exclusion Criteria

• •Presence or history of neurological disorders, including seizure disorders (abnormal EEG without seizures will not be excluded), PKU, tuberous sclerosis, Rett syndrome, Fragile X syndrome, Down Syndrome and traumatic brain injury.
• •Other medical or behavioral problems requiring medications which are centrally active.
• •Clinical or laboratory evidence of renal or hepatic disease (SGPT, GGT \> 2 x normal value, and serum creatinine \> 1.5 x normal value).
• •Treatment with any medication known to alter the activity of the CYP3A4 enzyme including ketoconazole, itraconazole, grapefruit juice, erythromycin, clarithromycin, cimetidine, verapamil, diltiazem, rifampin, phenytoin, phenobarbital, or carbamazepine within the previous 2 months and for the duration of the study is prohibited.
• •Use of centrally acting drugs during the 6 weeks prior or during the study. These drugs include but are not limited to neuroleptics, benzodiazepines, anticonvulsants and antidepressants. Shorter times may be considered depending on the half life of the drug.
• •Prior treatment for periods longer than two weeks with buspirone or selective serotonin reuptake inhibitors. This includes herbal substances such as St John's Wort which have similar pharmacological actions.
• •Known allergies to study medication.
• •Unable to provide the required blood samples.