Intranasal Oxytocin and Learning in Autism

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

The main objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when paired with a computer game intervention that is designed to enhance face perception skills.

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

The registry classes the interventions as drug.

More on the Plan

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.

Thus, the objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with ASD when paired with a computer game intervention that is designed to enhance face perception skills.

Who Took Part

The registry lists 36 actual participants 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: Participants aged 12-17 years, Mental age ≥ 10. Diagnosis of an Autism Spectrum Disorder. Consent: parent/guardian permission and child assent. Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English (and English as a first language).

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., intelligence quotient (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

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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

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

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

It started in 2011-09 with completion listed for 2015-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery) (time frame: Baseline and Post-testing (after max. 12 days)). Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version) (time frame: Baseline and Post-testing (after max. 12 days)).

It also tracked 1 secondary outcome, for example Changes From Baseline to Post-testing (After Max. 12 Days) on the "Happy Faces" Measure of Social Attention.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 36 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.