Intranasal Oxytocin in the Treatment of Autism

What Was Tested

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

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

Subjects were given placebo twice daily, in the morning and afternoon for 6 weeks.

The registry classes the interventions as drug.

More on the Plan

Autism is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning, and repetitive behaviors and restricted interests.

Given the likely possibility of dysregulated oxytocin in autism, the goal of this pilot study is to investigate the long-term therapeutic effects of oxytocin in the treatment of autism.

One practical issue with oxytocin is that it does not exist in a pill form.

Only the intravenous form is available in the United States and this form may or may not pass the blood-brain barrier.

Who Took Part

The registry lists 19 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Male or female outpatients 18 to 60 years of age. Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision. The diagnosis will be confirmed with Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule . Have a Clinician's Global Impression-Severity score ≥ 4 (moderately ill) at Screening and Baseline. The patient must be able to speak and understand English sufficiently to understand the nature of the study and to allow for the completion of all study assessments. Have a normal Intelligence Quotient (\>70) supported by the Wechsler Abbreviated Scales of Intelligence.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: patients born prior to 35 weeks gestational age; pregnant female patients; patients taking psychoactive medication(s) (e.g., stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clonidine).

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.

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 2006-06 with completion listed for 2011-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Repetitive Behavior Scale - Revised (time frame: 6 Weeks). Diagnostic Analysis of Nonverbal Accuracy, Paralanguage Test (time frame: 6 Weeks).

It also tracked 2 secondary outcomes, for example Yale-Brown Obsessive-Compulsive Scale and Social Responsiveness Scale.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 19 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.