A Controlled Study of Olanzapine in Children With Autism

Inclusion Criteria: 1. Males and females, Aged between 3 and 12 years. 2. Autistic disorder - DSM-IV criteria. 3. A score of at least moderately impaired on the CGI-Severity item. 4. Clinical judgment that medication treatment for autism is indicated. Exclusion Criteria: 1. Rett's disorder, childhood disintegrative disorder, Asperger's disorder, and PDD, NOS. 2. Psychotic disorder (DSM-IV) (including schizophreniform disorder and schizophrenia). 3. Major depressive disorder (DSM-IV). 4. Bipolar disorder (DSM-IV). 5. History of psychoactive drug in the previous 2 weeks prior to phase 1. 6. A history of treatment with olanzapine for a cumulative period of greater than 2 weeks prior to entering phase 1. 7. Systemic diseases such as cardiac, renal, thyroid diseases, uncontrolled seizure disorder (seizure disorder that is not controlled by anti-epileptic medication - a child who is seizure free for a period of 6 months on a stable dose of antiepileptic drug would be considered controlled), or diabetes mellitus. 8. Children with a known medical cause for autistic disorder. 9. Abnormal fasting blood glucose or history of diabetes. 10. Baseline body mass index (BMI) greater than the 90th percentile for age and gender (CDC growth charts, Kuczmarski et al, 2000) (because of risk of weight gain). 11. Baseline QTc \>450 msec. Note: Historically, patients we evaluate do not have QTc values \>450. 12. Dyskinesias at baseline (per the criteria of Schooler and Kane, 1982).