Intranasal Vasopressin Treatment in Children With Autism

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Vasopressin.

Vasopressin is a hormone that is produced naturally within the body and has been implicated in regulating social behaviors.

It had three arms (groups): Vasopressin-Vasopressin (experimental), Placebo-Vasopressin (experimental) and Placebo-Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 157 actual participants took part.

It was open to people of any sex aged from 6 years up to 17 years.

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

Examples of who could join: Males and females;. Intelligence quotient (IQ) of 40 and above;. Rating of 4 or higher on the Social Communication domain of the Clinical Global Impressions Severity (CGI-S);. Social Responsiveness Scale-2 Total Score of 70 and above;. Care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis;.

The full record lists 10 inclusion and 12 exclusion criteria; among the exclusions: DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder;; regular nasal obstruction or nosebleeds;; history of hypersensitivity to vasopressin, its analogs, or compounding preservatives (e.g., chlorobutanol);.

How the Study Was Run

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

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

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

As a double-blind Vasopressin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2018-02-20 with completion listed for 2024-03-18.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment (time frame: baseline, 4-week, 8-week).

It also tracked 28 secondary outcomes, for example Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment, Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment, Change From Baseline on the Facial Emotion Recognition Test During Treatment, Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment, Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment and Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Vasopressin in 157 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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