Effects of Intranasal Oxytocin on Emotion Regulation

What Was Tested

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

The aim is to examine whether intranasal oxytocin will influence the individuals' emotion regulation ability and related neural mechanisms.

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

Intranasal administration of oxytocin.

Intranasal administration of placebo.

The registry classes the interventions as drug.

More on the Plan

In the present study, the investigators plan to conduct a between-subject, double-blind, placebo-controlled experiment to investigate the effects of oxytocin on neural, physiological and behavior activity related to emotion regulation.

The emotion regulation ability will be assessed by emotional go-nogo task and cognitive reappraisal task.

The neural activity will be explored by functional magnetic resonance imaging (fMRI).

And the investigators will record participants' heart rate during fMRI to investigate the effects of oxytocin on heart rate variability in emotion regulation process.

Who Took Part

The registry lists 80 planned participants were the target.

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.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: history of head injury;; medical or psychiatric illness.

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.

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 2016-02 with completion listed for 2018-12.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Oxytocin effects on neural activity during emotion regulation task (time frame: Between 45-110 minutes after the intranasal administration of oxytocin).

It also tracked 4 secondary outcomes, for example Oxytocin effects on heart rate variability during emotion regulation task, Oxytocin effects on behavior response during emotion regulation task, Oxytocin effects on heart rate variability during resting-state and Oxytocin effects on neural activity during resting-state.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 80 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.