A Controlled Study of Olanzapine in Children With Autism

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).