A Double Blind, Randomized Clinical Trial of Oxytocin Nasal Spray to Improve Social Interaction and Reduce Repetitive Behaviours in Young Children Diagnosed with Autism Spectrum Disorders

Background:  Autism Spectrum Disorders (ASDs) are typically defined by a triad of impairments in social interaction, communication, and repetitive behaviour. Pharmacological treatments can provide some benefit in reducing the severity of repetitive and restricted behaviours, but they have no influence on the observed social difficulties. Behavioural interventions may provide some benefit, however these improvements are limited and bear significant costs. More affordable, accessible, and effective treatments are required. Recent advances in the field of social neuroscience suggest that the synthetic hormone, oxytocin, may provide a potential treatment to improve social and behavioural dysfunction in ASD.

Objectives:  The aim of this research is to determine the safety and effectiveness of oxytocin nasal spray in the treatment of social and behavioural difficulties for young children with ASDs. We aim to determine whether oxytocin nasal spray would improve social interaction, social cognition and reduce repetitive behaviours in comparison to placebo nasal spray.  Using early intervention models that suggest intervention is most effective when provided before the age of six, we target this treatment towards children aged between three and six years of age.

Methods:  This trial recruited 39 participants aged 3 and 8years of age who met DSM-IV-TR criteria for an ASD. In a double- blind, randomised cross-over design, participants were randomly assigned to receive oxytocin (12IU) and placebo nasal spray morning and night for the 5 week treatment course. 

Results:  The complete results of the trial will be presented at this conference. As this trial is yet to be accepted for publication, we do not report results within this abstract. We will discuss results, moderating factors, and limitations of the current studies at the time of presentation.

Conclusions:  To date, this clinical trial will be the first to demonstrate the effectiveness of oxytocin in improving social skills, social cognition and reducing repetitive behaviour in young children with ASDs aged between three and six years. This trial has important clinical and medical implications for the use of oxytocin as an early intervention treatment approach for symptoms of ASDs.