Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts

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

During the paradigm video clips of 25s lengths will be presented showing fear-inducing situations in social and non-social contexts as well as corresponding control video clips.

Following each clip subjects are required to rate their level of subjective fear on a rating scale ranging from 1 (no fear) to 9 (highest fear).

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

Together with a randomized assignment to the treatment groups, this will allow controlling for confounding between-group differences.

Who Took Part

Enrollment: 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

Design: 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.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant and investigator.

It started in 2023-05-23 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: BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI) (time frame: 45 minutes to 70 minutes after treatment).

It also tracked 1 secondary outcome, for example Experienced fear during the paradigm as assessed by self-reported ratings.

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.