Modulating Socially Adaptive Mirror System Functioning in Autism by Oxytocin

What Was Tested

This registered phase 3 trial tested Oxytocin.

The order of nasal spray will be randomised across participants.

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

The registry classes the interventions as drug and other.

More on the Plan

The brain's action observation network or 'mirror system' supports a variety of socio-cognitive functions, as it enables them to internally simulate and understand others' actions, emotions and intentions.

Generally, mirror responses are larger upon the observation of actions accompanied by relevant information for the observer, such as direct eye contact from the actor.

In other words, 'mirroring' is adaptively modulated according to the social salience of the observed actions (i.e. it is socially adaptive).

Individuals with Autism Spectrum Disorders (ASD) are known to endure difficulties with correctly recognizing eye contact as a communicative cue.

Who Took Part

The registry lists 25 actual participants took part.

It was open to men only aged from 18 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Young adults (between 18 - 35 y/o). Official diagnosis of Autism Spectrum Disorders (for ASD participants).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: any neuro(psycho)logical / psychiatric illness (for healthy controls); motor dysfunctions of the hands / arms.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

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

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

It started in 2018-07-26 with completion listed for 2019-12-19.

It ran at 1 site in Belgium.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change from baseline in socially adaptive mirroring as measured by TMS (time frame: 30 minutes after spray administration).

It also tracked 3 secondary outcomes, for example Change from baseline in mirroring of others' actions as measured by TMS, Change from baseline in corticospinal excitability as measured by TMS and Change from baseline in total fixation duration towards the eye region of the model.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 25 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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