Effects of Oxytocin on Emotion Recognition and Response Inhibition

What Was Tested

The trial (phase 2) is built around Oxytocin.

The purpose of this study is to shed light on the basic neurobiological mechanisms which underlie social information processing in healthy men.

More specifically, the researchers intend to examine whether a person's social competence level is related to the patterns of neural activity and his visual search strategies during evaluation of social scenes.

It had two arms (groups): Cross over Oxytocin and Placebo (experimental) and Cross over Placebo and Oxytocin (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Subject's ability to fully grasp the type, scope and individual consequences of the study. Willingness to participate in and comply with the study procedures as indicated by signing the dated informed consent form.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: regular intake of medication; hypersensitivity towards oxytocin or a chemically similar substance; current or previous neurological or psychiatric disorder.

How the Study Was Run

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

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 2015-01 with completion listed for 2017-01.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): BOLD response during emotion recognition in contrast with a corresponding control condition (time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])). BOLD response during response inhibition (Emotional Go/ Nogo) in contrast with a corresponding control condition (time frame: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])).

It also tracked 7 secondary outcomes, for example Serum levels of Oxytocin, Serum levels of Prolaktin, Serum levels of Cortisol, Total length of fixations on areas of interest (AOIs) assessed via eye-tracking, Number of fixations on areas of interest (AOIs) assessed via eye-tracking and Response time in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 40 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.