Ocytocine and Cerebral Activation in Relation With Attachement

What Was Tested

This registered phase 2 trial tested Oxytocin.

The study aims to characterize the cerebral activation modifications related to nasal oxytocin administration during vizualisation of distress images in population of healthy people with different attachement styles.

It had four arms (groups): one (experimental), avoidant (experimental), enmeshed/fearfull (experimental) and dual style (experimental).

Healthy adult male with avoidant attachement.

Healthy adult male with enmeshed/fearfull attachement.

The registry classes the interventions as behavioral, device and drug.

More on the Plan

Healthy adult male will be recruited.

Their attachement style will be assessed through the Attachement scale interview (ASI).

They will have 2 fMRI sessions, during which emotional images will be presented.

One session will be preceded by a nasal administration of oxytocin and the other session will be preceded by a placebo nasal administration.

Who Took Part

Enrollment: 100 actual participants took part.

It was open to men only aged from 18 years up to 30 years.

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

Examples of who could join: Comprehension of french. Having signed the informed consent.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: chronic disease (liver failure, kidney failure) and cardiovascular disease; hypertensive treatment; current hospitalisation.

How the Study Was Run

It was run as a randomized, crossover and quadruple-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.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

As a double-blind Oxytocin 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 2015-04-09 with completion listed for 2018-04-27.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: BOLD signal intensity (time frame: 45 min after intranasal administration of oxytocin or placebo).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 100 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.