Single Dose Intranasal Oxytocin and Cognitive Effects in Autism

What Was Tested

This registered phase 2 trial tested Oxytocin.

Autism spectrum disorder (ASD) is a group of severe, life-long developmental disorders.

Oxytocin (OT) is a neurohormone involved in both repetitive/rigid and social behaviors.

It had two arms (groups): Placebo (placebo comparator) and Intranasal Oxytocin (experimental).

Saline Nasal spray designed to look and feel like the drug intervention.

Oxytocin nasal spray designed to look as seem exactly like Placebo.

The registry classes the interventions as drug.

Who Took Part

27 actual participants took part.

It was open to people of any sex aged from 5 years up to 40 years.

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

Examples of who could join: Participants will be between 5 and 40 years of age. All subjects will have a diagnosis of autistic disorder or ASD that was confirmed by administration of the Autism Diagnostic Observation Schedule-WPS (ADOS-WPS) (30). Eligible participants must be able to perform the cognitive learning tasks.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: all female subjects of childbearing capacity will have a urine pregnancy test (a positive test will exclude the subject from participation).

How the Study Was Run

It was run as a randomized, crossover and quadruple-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.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

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

It started in 2014-05 with completion listed for 2021-03-31.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Reading the Mind in the Eyes Task (RMET) (time frame: 2 weeks). Rapid Automatized Naming (RAN) (time frame: 2 weeks). Dynamic Affect Recognition Evaluation (DARE) (time frame: 2 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 27 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.