Intranasal Oxytocin for the Treatment of Children and Adolescents With ASD (OXY)

What Was Tested

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

A medication treatment targeting the core deficits of Autism Spectrum Disorder in childhood is highly valuable because it could influence the developmental trajectory and make further psychosocial interventions possible.

It had 1 arm (groups): Intanasal Oxytocin (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 10 years up to 17 years.

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

Examples of who could join: Male or female outpatients 10-17 years of age inclusive. Have a Clinician's Global Impression-Severity score ≥ 4 (moderately ill) at Baseline. Verbal Intelligent Quotient \>/= 70. The participant and caregiver must be able to speak and understand English sufficiently to allow for the completion of all study assessments.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: patients born prior to 35 weeks gestational age; patients with any primary psychiatric diagnosis other than autism at screening; pregnant female patients, sexually active female patients on hormonal birth control and sexually active females who do not use two types of non-hormonal birth control.

How the Study Was Run

Design: 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 2010-11 with completion listed for 2013-03.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Serious Adverse Events (time frame: 24 Weeks).

It also tracked 2 secondary outcomes, for example Baseline Levels of Oxytocin in Relation to Either Safety or Treatment Response and Blood Levels of Oxytocin During the Trial in Relation to Safety or Treatment Response.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Oxytocin in 15 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.