Intranasal Oxytocin and Learning in Autism

What Was Tested

This registered phase 2 trial tested Oxytocin.

The researchers designate two measures as their primary outcomes, based on prior published work with these interventions, and the researchers propose a sample based on power analyses from these prior results.

It had two arms (groups): Placebo Group (placebo comparator) and Experimental Group (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

Diagnosis will be confirmed using Diagnostic and Statistical Manual (DSM) criteria, supported by the Autism Diagnostic Interview and the Autism Diagnostic Observation Schedule.

Measures of social function and cognition will be administered before and after the game play period.

The effects of this type of social intervention may be amplified with the concurrent use of oxytocin.

Furthermore, these learning effects may impact social skills in general and translate to the level of the individual's everyday social behavior.

Who Took Part

It was open to men only aged from 12 years up to 17 years.

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

Examples of who could join: Subjects aged 12-17 years, Mental age ≥ 7 (as measured by an IQ test such as the Differential Ability Scales II). Diagnosis of an ASD. Consent: parent/guardian permission and child assent. Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: gestational age below 35 weeks and/or perinatal injury; profound mental retardation (e.g., iq \< 45) or sensory-motor difficulties that would preclude valid use of diagnostic instruments; lack of impairment in face recognition as determined by average or above average performance on the benton face recognition task.

How the Study Was Run

It was run as a randomized, parallel-group and triple-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.

The Oxytocin group and the comparison group ran side by side rather than switching.

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

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

It started in 2014-03 with completion listed for 2018-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from Baseline to Post-testing on the The Part/Whole Identity Test (time frame: Baseline/Follow-up post testing (max 12 days)). Change from Baseline to Post-testing on the Reading the Mind in the Eyes Task (time frame: Baseline to Post-testing (max. 12 days)).

It also tracked 1 secondary outcome, for example Change from Baseline to Post-testing on measures of social attention, reward/motivation, perception and cognition.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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