Intranasal Oxytocin Treatment for Social Deficits in Children With Autism

What Was Tested

This registered phase 2 trial tested Oxytocin.

Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication, and the presence of repetitive or stereotyped behaviors.

It is one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88 children in the United States.

It had two arms (groups): Oxytocin nasal spray (active comparator) and Placebo nasal spray (placebo comparator).

The placebo nasal spray bottles will be prepared by adding all of the ingredients used in the Syntocinon nasal sprays with the exception of the concentrated oxytocin solution.

The registry classes the interventions as drug.

More on the Plan

In recent years, the neuropeptide oxytocin (OT) has been implicated in a wide range of social behaviors including attachment bonds, emotion recognition, eye gaze to social cues, and memory for social information.

The primary outcome for this study is change in social behavior, as determined by parent ratings on the Social Responsiveness Scale (SRS) after the 4-week treatment period.

On completion of the 4-week treatment period all subjects will have the option of participating in another 4-week double-blind trial in which they will be switched to the alternate nasal spray to that which they previously received.

By providing subjects with the option of participating in a second 4-week treatment trial, all subjects will have an opportunity to receive the active oxytocin nasal spray.

Who Took Part

Enrollment: 54 actual participants took part.

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: Medically healthy outpatients between 6 and 12 years of age (cut off 12 years and 11 months). Intelligence Quotient \> 40. Diagnosis of autism spectrum disorder based on the Autism Diagnostic Interview - Revised, Autism Diagnostic Observation Schedule, and DSM-IV criteria. Clinical Global Impression severity rating of 4 or higher. Care provider who can reliably bring subject to clinic visits, provide trustworthy ratings, and interacts with the subject on a regular basis.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: diagnostics and statistical manual of mental disorders, 4th edition (dsm-iv) diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder; regular nasal obstruction or nosebleeds; sensitivity to preservatives (in particular e 216, e 218, and chlorobutanol hemihydrate).

How the Study Was Run

Design: 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 2012-06 with completion listed for 2016-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment (time frame: Baseline; Week 4).

It also tracked 16 secondary outcomes, for example Change From Baseline in Height, Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4, Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment, Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment, Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment and Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 54 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.