Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD)

What Was Tested

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

The researchers are studying an investigational drug called intranasal oxytocin (Syntocinon®).

Syntocinon® has been approved by the U.S.

Food and Drug Administration for use in helping women breastfeed, but it has not been approved for use in children with ASD.

It had two arms (groups): Intranasal Oxytocin (Syntocinon) (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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

In this context, the researchers propose a randomized placebo controlled trial of intranasal oxytocin in children and adolescents with ASD.

Who Took Part

60 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 (CGI-S) score ≥ 4 (moderately ill) at Screening. Verbal and performance scale Intelligence Quotient (IQ) ≥ 70 (both subtests of the Wechsler Abbreviated Scale of Intelligence (WASI-I or WASI-II ≥ 70). Ability to speak and understand English sufficiently to allow for the completion of all study assessments.

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: patients born prior to 35 weeks gestational age; patients with a primary psychiatric diagnosis other than asd; patients who are currently taking oxytocin or have taken intranasal oxytocin in the past with no response.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

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 2013-09 with completion listed for 2015-09.

It ran at 2 sites in United States (1) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 10 secondary outcomes, for example Number of Participant Considered Social Responders, Number of Participant Considered Overall Responders and Safety and Tolerability of Intranasal Oxytocin in Children and Adolescents With ASD.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 60 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.