Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders

What Was Tested

The trial (not phased) is built around Oxytocin.

Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning and repetitive behaviors and restricted interests.

Moreover, OT is known to play an important role in repetitive behaviors and stress reactivity.

It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 19 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and Female. 18 to 55 years old. Meet Diagnostic and Statistical Manual-IV (DSM-IV), Autism Diagnostic Observation Schedule(ADOS), and Autism Diagnostic Interview-Revised (ADI-R) standards for Autism Spectrum Disorder or Aspergers Syndrome. Have a high, normal or near normal Intelligent Quotient. Speak and Understand English fluently.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: born prior to 35 weeks gestational age; any primary psychiatric diagnosis other than autism at the time of screening; patients who are pregnant.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Oxytocin group and the comparison group ran side by side rather than switching.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-10 with completion listed for 2013-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Change in Obsessive- Compulsive Behavior Based on Yale Brown Obsessive Compulsive Scale (YBOCS), Change in Repetitive Behavior Based Repetitive Behavior Scale - Revised (RBS-R) and Change in Facial Emotion Recognition Based on Diagnostic Analysis of Nonverbal Accuracy - 2 (DANVA-2).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 19 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.