INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders

What Was Tested

The trial (phase 2) is built around Oxytocin.

As a large number of children with ASD are transitioning into adulthood and will likely require treatment, the lack of data to make meaningful treatment recommendations to facilitate adult living is an urgent issue.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 70 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Male or female outpatients 18-45 years of age, inclusive. Have a Clinical Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Screening. Verbal scale Intelligence Quotient (IQ) ≥ 70. Ability to speak and understand English sufficiently to allow for the completion of all study assessments.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: patients born prior to 28 weeks gestational age; patients with a primary psychiatric diagnosis other than asd; patients unable to tolerate venipuncture procedures for blood sampling.

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 2014-06 with completion listed for 2017-08.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example Safety and tolerability of intranasal oxytocin in adults with ASD and Safety and tolerability of intranasal oxytocin in adults with ASD.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 70 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.