Influence of Oxytocin on Resting State Neurophysiological Measures

What Was Tested

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

In this study, the investigators will explore the influence of oxytocin administration on several neurophysiological responses (EEG, skin conductance and heart rate) during rest.

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

The registry classes the interventions as drug.

More on the Plan

Oxytocin is known to influence several neurophysiological measures, such as heart rate, EEG and skin conductance during specific tasks (e.g., emotion recognition, fear learning and extinction).

However, not much is known about the influence of oxytocin on those measures during rest.

Therefore, in this randomized, placebo controlled, double blinded study, the investigators will investigate the influence of oxytocin during a resting period of 5 minutes.

Heart rate, skin conductance, respiration and EEG will be measured before and after oxytocin or placebo administration.

Who Took Part

Enrollment: 56 actual participants took part.

It was open to men only aged from 18 years up to 38 years.

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

Examples of who could join: Age between 18 and 35. Normal or adjusted-to-normal vision (with lenses only). Dutch as mother tongue.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: not right-handed; age below 18 or above 35; need to wear glasses.

How the Study Was Run

The set-up was randomized, parallel-group and triple-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, investigator and outcomes assessor.

It started in 2017-07-24 with completion listed for 2018-05-18.

It ran at 1 site in Belgium.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in heart rate variability after oxytocin administration (time frame: Assessment over 5 minutes, before and after oxytocin or placebo administration).

It also tracked 1 secondary outcome, for example Change in skin conductance level after oxytocin administration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 56 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.