A Study of Oxytocin in Children and Adolescents With Autistic Disorder

What Was Tested

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

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

Intervention: Drug: placebo.

Intervention: Drug: Syntocinon® Nasal Spray.

The registry classes the interventions as drug.

More on the Plan

Overall, this study aims to determine the tolerability, accessibility, and feasibility of an oxytocin pilot study.

This will also help to develop systematic preliminary safety measures.

Who Took Part

25 actual participants took part.

It was open to people of any sex aged from 3 years up to 17 years.

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

Examples of who could join: Between 3 and 17 years old, inclusive.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: marked sensory impairment such as deafness or blindness that would interfere with conduct of the study; inability of caretakers to speak english; absence of a consistent caretaker to report on symptoms.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-03 with completion listed for 2013-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants Who Could Tolerate Twice Daily Oxytocin (time frame: Week 0 to week 8). Number of Participants Who Could Tolerate Twice Daily Oxytocin (time frame: Week 0 to week 16).

It also tracked 9 secondary outcomes, for example Change in Mean Plasma Oxytocin Level During Period 1 - Double Blind Phase, Change in Mean Weight, Change in Mean Total Social Social Responsiveness Scale (SRS) T-score, Change in Mean Aberrant Behavior Checklist (ABC)-Social Withdrawal Subscale Score Over Both Periods, Change in Mean Pervasive Developmental Disorder Behavior Inventory - Screening Version (PDDBI-SV) Total Score Over Both Periods and Change in Mean Systolic Blood Pressure During Period 1.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 25 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.