Objectives: Conventional neuroleptics ameliorate symptoms in children with
autistic disorder; however, they are known to cause dyskinesias. Atypical n
euroleptics, including olanzapine, may have less risk for dyskinesia, but t
heir efficacy in autistic disorder is not established. This study was desig
ned to investigate the safety and effectiveness of open-label olanzapine as
a treatment for children with autistic disorder by using haloperidol as a
standard comparator treatment. Method: In a parallel groups design, 12 chil
dren with DSM-I autistic disorder (mean age 7.8 +/- 2.1 years) were randomi
zed to 6 weeks of open treatment with olanzapine or haloperidol. Mean final
dosages were 7.9 +/- 2.5 mg/day for olanzapine and 1.4 +/- 0.7 mg/day for
haloperidol. Outcome measures included the Clinical Global Impressions (CGI
) and the Children's Psychiatric Rating Scale (CPRS). Results: Both groups
had symptom reduction. Five of six in the olanzapine group and three of six
in the haloperidol group were rated as responders according to the CGI Imp
rovement item. Subjects showed improvement on the CPRS Autism Factor (F-1,F
-9 = 24.4, p = .0008). Side effects included drowsiness and weight gain. Co
nclusions: The findings suggest that olanzapine is a promising treatment fo
r children with autistic disorder. Further placebo-controlled and long-term
studies of olanzapine in autistic disorder are required.