Effect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Oxytocin.

The purpose of this study is to learn more about how the hormone, oxytocin, impacts social behavior in terms of cooperation with others, attention processing, and reward processing, among patients with social anxiety disorder.

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

Matched placebo nasal spray.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

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

Examples of who could join: Males \> 18 years of age with a primary (or co-principal) psychiatric diagnosis of social anxiety disorder (SAD), as defined by Diagnostic and Statistical Manual-IV (DSM-IV) criteria;. Current Liebowitz Social Anxiety Scale (LSAS) score \> 60, which is a clinical threshold for SAD symptoms;. Willingness to participate in and comply with the study procedures as indicated by signing the informed consent form.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: subjects with a serious medical illness for which hospitalization may be likely within the next three months;; active suicidal or homicidal ideation or suicide attempts within the past six months requiring hospitalization;; smokers who smoke more than 15 cigarettes per day;.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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 2012-07 with completion listed for 2013-08.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Social Cooperation (time frame: Day 1 (first day oxytocin or placebo was administered)). Disengagement From Social Threat Cues (time frame: Day 1 (first day oxytocin or placebo was administered)).

It also tracked 4 secondary outcomes, for example Perceived Trust Scores on a 1-7 Likert Scale, Perceived Empathy Scores on a 1-7 Likert Scale, Perceived Preference Scores on a 1-7 Likert Scale and Perceived Rejection Scores on a 1-7 Likert Scale.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 60 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.