A Controlled Study of Olanzapine in Children With Autism

Inclusion criteria

• Males and females, Aged between 3 and 12 years.
• Autistic disorder - DSM-IV criteria.
• A score of at least moderately impaired on the CGI-Severity item.
• Clinical judgment that medication treatment for autism is indicated.

Exclusion criteria

• Rett's disorder, childhood disintegrative disorder, Asperger's disorder, and PDD, NOS.
• Psychotic disorder (DSM-IV) (including schizophreniform disorder and schizophrenia).
• Major depressive disorder (DSM-IV).
• Bipolar disorder (DSM-IV).
• History of psychoactive drug in the previous 2 weeks prior to phase 1.
• A history of treatment with olanzapine for a cumulative period of greater than 2 weeks prior to entering phase 1.
• 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.
• Children with a known medical cause for autistic disorder.
• Abnormal fasting blood glucose or history of diabetes.
• 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).
• Baseline QTc >450 msec. Note: Historically, patients we evaluate do not have QTc values >450.
• Dyskinesias at baseline (per the criteria of Schooler and Kane, 1982).