Neural and Behavioral Effects of Oxytocin in Autism Spectrum Disorders

What Was Tested

The trial (phase 4) is built around Oxytocin.

The current trial aims to explore the neural and behavioral effects of oxytocin in autism spectrum disorders (ASD).

Oxytocin is a nonapeptide produced by the paraventricular and supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of complex social behaviors.

It had two arms (groups): Syntocinon (Oxytocin, product code RVG 03716) (experimental) and Placebo (Physiological water(sodium chloride (NaCl) solution)) (placebo comparator).

Administration via nasal spray.

Administration via nasal spray.

The registry classes the interventions as drug and other.

More on the Plan

The present study is a monocentric, between-subjects, randomized, placebo-controlled trial.

The investigators will recruit approximately 40 young-adult, male individuals with a clinical diagnosis of Autism Spectrum Disorder (ASD).

Participants will be randomly allocated to an experimental group (Oxytocin (OT)) and a control group (Placebo (PL)).

All participants will receive the same frequency and duration of intervention.

Who Took Part

The registry lists 40 actual participants took part.

It was open to men only aged from 18 years up to 40 years.

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

Examples of who could join: Clinical diagnosis of Autism Spectrum Disorder, Asperger Syndrome or Autism. Age between 18 and 40 years old.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: associated neuro(psycho)logical disorder (i.e. epilepsy, concussion, stroke); eye sight worse than + or - 7; genetic syndrome.

How the Study Was Run

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

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 2015-04 with completion listed for 2016-12.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray (time frame: Value at 4 weeks minus value at baseline). Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (time frame: Value at 8 weeks minus value at baseline). Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (time frame: Value at 52 weeks minus value at baseline).

It also tracked 8 secondary outcomes, for example Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 4 Weeks of Nasal Spray.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 40 people.

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.