ABSTRACT
To study the efficacy and safety of olanzapine for the treatment of children with autism associated with disruptive behavior problems. A prospective open-label trial was conducted on 40 male children [mean age 12.2 +/- 2.2 years, range 7-17 years] meeting Diagnostic Statistical Manual IV criteria for autism. After a washout period from previous medications [2-14 days], patients received olanzapine [5-10 mg/day] for a 13-week treatment period. The primary efficacy measures were Aberrant Behavior Checklist [ABC] and Clinical Global Impressions-Severity [CGI-S] done at baseline and end of treatment. At the beginning and end of treatment, patients underwent laboratory and physical investigations: ECG, chest X-ray, urinalysis, serum chemistry, blood glucose and lipid profile, hematology and hepatitis B serology. Paired comparison of baseline and 13-week endpoint scores showed significant reductions in ABC subscale scores for irritability [p < 0.0001], lethargy [p < 0.0001], stereotyped behavior [p < 0.005], hyperactivity [p < 0.0001] and inappropriate speech [p < 0.005]. Of 40 patients, 12 [30%] were considered as 'improved' on CGI-S scores compared to baseline, a statistically significant difference [p < 0.05]. No liver enzyme elevation or any other serum biochemical changes resulted from treatment, which was not associated with significant body weight changes or any other treatment-emergent side effects. The study shows that olanzapine treatment can be beneficial in alleviating some behavioral symptoms [irritability, hyperactivity/noncompliance and lethargy/withdrawal] associated with autism. The short period of this trial limits inferences about adverse effects such as body weight increase and tardive dyskinesia. Further long-term placebo-controlled studies of olanzapine are required