Translating Neuroprediction Into Precision Medicine Via Brain Priming

What Was Tested

The trial (phase 2) is built around Oxytocin.

The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT) on the development of language, social, and play skills in young children with Autism Spectrum Disorder (ASD).

The purpose of this study is to examine the impact of OXT as an enhancer of response to PRT.

Participants will be randomly assigned to either an intranasal OXT group or a placebo group.

It had two arms (groups): Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray (experimental) and Pivotal Response Treatment (PRT)/placebo nasal spray (placebo comparator).

Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.

Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.

The registry classes the interventions as behavioral and drug.

More on the Plan

The researchers will integrate fMRI, eye tracking, and behavioral outcomes to measure how OXT may create a neural background for individuals with ASD to bolster their motivation to interact socially and facilitate their biological preparedness for learning social communication skills during behavioral treatments.

Who Took Part

Enrollment: 5 actual participants took part.

It was open to people of any sex aged from 5 years up to 9 years.

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

Examples of who could join: Fit the age requirement: age 5-9. Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team. Be in good medical health. Be cooperative with testing. Speak English in the family.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: any metal or electromagnetic implants, including:; cardiac pacemaker; artificial heart valve.

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.

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

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 2018-12-07 with completion listed for 2021-07-28.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Social Responsiveness Scale, 2nd Edition (SRS-2) (time frame: Change from Baseline to post-treatment, 16 weeks).

It also tracked 1 secondary outcome, for example Vineland Adaptive Behavior Scale, 3rd Edition (Vineland-III).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 5 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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