Interest of Oxytocin as an Adjuvant Treatment of Psycho-educational Measures in Challenging Behaviors in Children With Autism Spectrum Disorders and Moderate to Severe Intellectual Disability: Feasibility and Safety Study.

What Was Tested

This registered phase 2 trial tested Oxytocin.

The investigation team propose in this study to specifically evaluate the feasibility of using oxytocin in the form of an intranasal spray in a specific population of children with autism spectrum disorder and intellectual disability.

The lack of studies centered on this population on the one hand, and on the other hand the severity of challenging behaviors presented by these children, make questionable the direct transfer of methods of care used in patients who do not present these challenging behavior.

In this sense, the establishment of oxytocin treatment in these children requires a preliminary phase of feasibility assessment before being able to consider a comparative trial of the randomized clinical trial type.

It had 1 arm (groups): intranasal oxytocin (experimental).

Intranasal oxytocin treatment once a day during 6 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 6 years up to 12 years.

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

Examples of who could join: Diagnosis:autism spectrum disorder according to the Diagnostic and Statistical Manual DSM -5 of severe intensity;. Moderate to severe intellectual disability. Presence of challenging behavior objectified by means of clinical examination and the ABC and ABC-I scales. If prescribed psychotropic treatments (antipsychotics, anxiolytics, hypnotics/sedatives, antidepressants, psychostimulants and antiepileptics), the dosages must be stable for 3 months\*. Understanding of French by both parents (if applicable) and ability for both parents to understand, in particular, the instructions for administering the product and to answer questionnaires.

The full record lists 9 inclusion and 18 exclusion criteria; among the exclusions: the refusal of the holders of parental authority; pregnant girls, determined by a positive baseline blood pregnancy test; criteria respecting the syntocinon spc:.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-07 with completion listed for 2026-12.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: percentage of children with complete OT administration protocol (time frame: Week 14). percentage of children with complete monitoring protocol (time frame: week 14).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Oxytocin in 30 people.

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

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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