Brain Imaging of Intranasal Oxytocin Treatment in Autism

What Was Tested

This registered phase 1 trial tested Oxytocin.

Time course of effect will also be assessed within session.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Joe Piven -U54 HD079124-01) Hypothesis 1b. will spend proportionally more time attending to the social image on a screen vs. the non-social image compared to placebo.

Who Took Part

Enrollment: 33 actual participants took part.

It was open to people of any sex aged from 6 years up to 18 years.

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

Examples of who could join: Between 6 and 18 years of age, inclusive. Male or female of any race or ethnicity. Ambulatory status (outpatient) at time of assent/consent. Estimated IQ greater than or equal to 70 and capable of making an informed decision based on assessment of their understanding and judgment.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: history of claustrophobia; marked sensory impairment such as deafness or blindness that would interfere with the conduct of the study; refusal to do pregnancy testing with understanding that guardian will be informed of positive test results.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2014-09 with completion listed for 2017-01.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Aim 1a. fMRI Activation Analysis/Connectivity. Aim 1b. Proportion of Time Attending to Social Stimuli (Eye Tracking).

It also tracked 5 secondary outcomes, for example Plasma Oxytocin (OT) levels in aim 1b. and 2b, Salivary Oxytocin (OT) levels for all aims, SRS-Social Responsiveness Scale and ABC-lethargy/social withdrawal subscale.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 33 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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