A Study of Oxytocin in Children and Adolescents With Autistic Disorder

The proposed pilot study is an essential first step toward rigorously evaluating oxytocin
treatment of individuals with autism. The biologic actions of oxytocin on social cognition
and prosocial behaviors and the clinical, genetic and epigenetic evidence for involvement of
the oxytocin system in the pathophysiology of some cases of autism strongly suggest that
supplemental oxytocin therapy could significantly improve the social disabilities involved
in autism. Many people feel that these social difficulties are the most characteristic and
central feature of autism. Overall, this study aims to determine the tolerability,
accessibility, and feasibility of an oxytocin pilot study.

This study will consent up to 30 subjects in order to randomize up to 24 subjects into a
2-month (8 weeks) randomized double-blind, placebo-controlled initial treatment period, a
subsequent 2-month (8 weeks) period in which all participants receive oxytocin, and two
post-treatment visits that occur at week 28 (±2 weeks) and some time before week 76. The
investigators hope that this study will help to inform future study designs in determining
whether a short term or long term treatment trial is necessary to observe significant
effects. This will also help to develop systematic preliminary safety measures.