Oxytocin and the Social Brain

What Was Tested

The trial (early phase 1) is built around Oxytocin.

It has long been established that interpersonal relationships can have a profound impact on health and well-being.

Yet, the investigators are still learning about the complex biological processes that contribute to positive social interactions and the ability to develop and maintain social relationships.

It had two arms (groups): Intranasal oxytocin (experimental) and Intranasal placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 161 actual participants took part.

It was open to people of any sex aged from 18 years up to 30 years.

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

Examples of who could join: 18-30 years of age. Healthy (see below). Fluent in English.

The full record lists 4 inclusion and 31 exclusion criteria; among the exclusions: women who gave birth in the last six months, are currently pregnant, planning to become pregnant in the next 6 months, or currently breastfeeding women; symptoms of runny nose due to allergies/cold or other reason; current restricted fluid intake for any reason.

How the Study Was Run

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

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.

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

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 2015-01 with completion listed for 2016-07.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Changes in neural brain activity, as observed by fMRI, when observing others during social inclusion vs. exclusion (time frame: Between 40-115 minutes post administration).

It also tracked 5 secondary outcomes, for example Ratings of empathic concern after witnessing social exclusion in a friend or a stranger, Altruism and punishment as measured by number of points given to excluders and those excluded, Changes in neural brain activity, as observed by fMRI, while attempting to detect deception, Accuracy of deception detection as measured by self-report and Changes in neural brain activity, as observed by fMRI, when viewing images of primary caregivers versus strangers.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 161 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.