Oxytocin in Spectrum Autism Disorders

What Was Tested

This registered phase 1 trial tested Oxytocin.

Observe effects of oxytocin on individuals with autism spectrum disorder.

It had two arms (groups): oxytocin spray (experimental) and placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

To observe the effects of oxytocin on individuals with autism spectrum disorder according to gender, in facial recognition and eye tracking tests.

The next week the volunteer will return and will do the same procedure because whoever took the placebo would take oxytocin and vice versa.

Is a randomized, double-blind, placebo-controlled clinical trial.

Who Took Part

Enrollment: 80 actual participants took part.

It was open to people of any sex aged from 3 years up to 16 years.

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

Examples of who could join: Age between 3 and 16 years. Stable (3 months with medication maintained or without medication).

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: pregnant women, infants and; use of pituitary hormones, cortisol, androgens and estrogens; heart problems: recent ami, heart failure.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

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

It started in 2016-07-15 with completion listed for 2017-07-20.

It ran at 1 site in Brazil.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Eye tracking (time frame: on average of 1 year).

It also tracked 1 secondary outcome, for example Nepsy.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 80 people.

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.