Social Safety Learning in the Brain Oxytocin System

What Was Tested

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

The investigators are conducting this research study to examine whether oxytocin enhances social safety learning (learning safety through the experience of another individual) in people with social anxiety disorder (SAD) compared to healthy volunteers.

Oxytocin is a hormone that can also act as a chemical messenger in the brain.

Oxytocin plays a role in a number of functions, including responding to fear and social interactions.

It had two arms (groups): Clinical (experimental) and Controls (placebo comparator).

This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive either an oxytocin or placebo administration (blind randomization).

This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive either an oxytocin or placebo administration (blind randomization).

The registry classes the interventions as drug.

More on the Plan

The goal of the current study is to examine the potential role of oxytocin in enhancing social learning in SAD.

The investigators' primary hypothesis is that vicarious extinction learning will contribute to safety learning and that oxytocin will potentiate vicarious extinction learning in patients with SAD, compared to healthy controls (HC).

Participants will receive oxytocin or placebo prior to the extinction phase.

The investigators will also measure skin conductance responses as an index of learning in each phase.

Who Took Part

121 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Men and women age 18-45. Women must be having regular menstrual cycles and not be taking oral contraception. Primary diagnosis of social anxiety disorder. Men and women age 18-45. Women must be having regular menstrual cycles and not be taking oral contraception.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: pregnancy or breastfeeding; positive urine drug screening test result; history of nasal pathology.

How the Study Was Run

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

Because people in this Oxytocin 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 Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2023-06-26 with completion listed for 2024-09-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Extinction Phase (time frame: immediately (45 minutes) after receiving drug). Neural Responses in the CS+R vs CS+S Contrast in the Hippocampus During the Extinction Phase (time frame: immediately (45 minutes) after receiving drug). Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Extinction Phase (time frame: immediately (45 minutes) after receiving drug).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 121 people.

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.