The Role of Vasopressin in the Social Deficits of Autism

What Was Tested

The trial (phase 2) is built around Vasopressin.

Difficulty with social interactions is characteristic of people with autism, who often have problems interpreting facial expressions or maintaining eye contact while talking with someone.

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

Placebo Nasal Spray.

Vasopressin Nasal Spray.

The registry classes the interventions as drug.

Who Took Part

The registry lists 68 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: Social Responsiveness Scale (SRS) Total Score equal to or greater than 70. Ability to complete laboratory and cognitive testing. Diagnosis of Autism Spectrum Disorder (ASD) based on expert clinical opinion and confirmed on the Autism Diagnostic Interview-Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS). Clinical Global Impression (CGI) severity rating of 4 or higher. Care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interact with the participant on a regular basis.

The full record lists 11 inclusion and 12 exclusion criteria; among the exclusions: diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or psychotic disorder; regular nasal obstruction or nosebleeds; active and unstable medical problems (e.g., migraine; asthma; seizure disorder; anaphylaxis; epilepsy; diabetes; serious liver, renal, or cardiac pathology).

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Vasopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 Vasopressin, so expectations could not easily colour the readings.

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

It started in 2013-12 with completion listed for 2017-05-30.

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, 2nd Edition (SRS-2) T-Score After Treatment (time frame: Baseline; Week 4).

It also tracked 20 secondary outcomes, for example Change From Baseline in Clinical Global Impression (CGI) Severity, Social and Communication Scores During Treatment, Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment, Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment, Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment, Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment and Change From Baseline on the Overt Aggression Scale (OAS) During Treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Vasopressin in 68 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.