Effect of a novel nasal oxytocin spray with enhanced bioavailability on autism: a randomized trial

What Was Tested

The paper reports a study of Oxytocin, published as a randomized controlled trial.

The primary outcome was the mean difference in the reciprocity score (range: 0-14, higher values represent worse outcomes) on the Autism Diagnostic Observation Schedule between the baseline and end point of each administration period.

This trial with two administration periods and eight groups was conducted at seven university hospitals in Japan, enrolling adult males with high-functioning autism spectrum disorder.

Who Took Part

PubMed tags the participants as both men and women.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled, crossover, multicenter and parallel-group.

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

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

The comparison arm used a placebo, so changes seen with Oxytocin could be set against what happens without it.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

Of 109 males with high-functioning autism spectrum disorder who were randomized, 103 completed the trial.

What Was Measured

The primary outcome was the mean difference in the reciprocity score (range: 0-14, higher values represent worse outcomes) on the Autism Diagnostic Observation Schedule between the baseline and end point of each administration period.

Topics PubMed links to this paper include Autism Spectrum Disorder, Autistic Disorder, Biological Availability, Nasal Sprays, Oxytocin and Rabbits.

The authors tagged it with the keywords Asperger, developmental disorder and neuropeptide.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Oxytocin.

The publication is from 2022 (Brain : a journal of neurology), a journal based in England.

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