A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder

What Was Tested

In this phase 3 trial, researchers set out to test Oxytocin.

This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment for social impairment in children and adults with high functioning autism spectrum disorders (ASD).

It had two arms (groups): Oxytocin- Participants ages 12-17 (experimental) and Oxytocin- Participants ages 18-55 (experimental).

The registry classes the interventions as drug.

Who Took Part

7 actual participants took part.

It was open to people of any sex aged from 12 years up to 55 years.

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

Examples of who could join: Males and females between 12 and 55 years of age. Meets the DSM-5 diagnostic criteria for Autism Spectrum Disorder (ASD) as established by clinical diagnostic interview. At least moderate severity of ASD impairment as measured by a raw score of ≥85 on the SRS. Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent. Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.

The full record lists 14 inclusion and 12 exclusion criteria; among the exclusions: impaired intellectual functioning and/or impaired spoken language; clinically unstable psychiatric conditions; any serious medical illness.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Being open-label, the Oxytocin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-10-09 with completion listed for 2019-01-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8 (time frame: 8 weeks).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Oxytocin in 7 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.