The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders

What Was Tested

This registered phase 2 trial tested Oxytocin.

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

The registry classes the interventions as drug.

More on the Plan

Participants receive a one-time administration of 24-IU intranasal oxytocin (or placebo) and perform an empathic accuracy task, a novel and ecologically valid measure of complex social cognition, in conjunction with functional magnetic resonance imaging (fMRI).

The investigators will investigate the effects of oxytocin (versus placebo) on the behavioral and neural correlates of empathic accuracy.

Who Took Part

The registry lists 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: In good physical health. Meet criteria for ASD according to psychiatric interview using the Diagnostic and Statistic Manual, Fourth Edition (DSM-IV). Must be a history of developmental delay. Capability of performing experimental tasks (i.e. can read and understand task instructions, cooperate with procedures). Informed consent and capacity.

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: participants with any primary psychiatric diagnosis at screening; participants who are pregnant, who gave birth in the last six months, or who are currently breastfeeding; participants with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.

How the Study Was Run

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

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.

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 and investigator.

It started in 2010-06-18 with completion listed for 2014-04-25.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Empathic Accuracy Performance (time frame: 45 minutes after drug/placebo administration). Fmri BOLD Response During Empathic Accuracy Task (time frame: 45 minutes after oxytocin/placebo administration).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 30 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.