Effects of Oxytocin on the Functional Architecture of the Brain Before and After Prolonged Naturalistic Fear Induction

What Was Tested

The trial (not phased) is built around Oxytocin.

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

Drug: intranasal Placebo.

The registry classes the interventions as drug.

More on the Plan

Following treatment administration subjects will undergo a resting state functional magnetic resonance imaging (fMRI) assessment (8min) and next watch a long fear-inducing (horror) movie (10min) followed by a resting state fMRI assessment (8min).

Effects of treatment on subjective experience will be assessed using 1-9 Likert scales assessing subjective fear, emotional arousal and escape.

Ratings will be acquired before the start of the experiment, after the movie and at the end of the experiment.

Participants will undergo screening for psychopathological and emotional states before treatment.

Who Took Part

69 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: Healthy subjects without past or current psychiatric or neurological disorders. Normal or corrected-normal version.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: history of head injury; medical or psychiatric illness; general cardio-vascular alteration or diseases.

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.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2023-05-29 with completion listed for 2024-04-01.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Functional connectivity during the resting state between brain systems involved in emotional processing.

It also tracked 1 secondary outcome, for example Functional and dynamic connectivity during the movie clip will be examined during the fear-induction period (10min movie clip).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 69 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.