The Influence of Oxytocin on Socio-communicative Sensitivity

What Was Tested

The trial (phase 1, phase 2) is built around Oxytocin.

Oxytocin (OT) is a neuropeptide that acts as a neurotransmitter and neuromodulator in the brain.

In the current study, the researchers want to gain more insight into the underlying mechanisms by which OT influences emotion recognition.

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

Physiological water (sodium chloride (NaCl) solution) Administration via nasal spray.

The registry classes the interventions as drug and other.

More on the Plan

The present study is a double-blind, randomized, placebo-controlled, crossover clinical trial, in which (approximately 30) neurotypical male adults (18 to 30 years old) will participate.

All participants will perform two sessions (OT and placebo), separated by two weeks.

For the first session, the participants are randomly assigned to the placebo or the OT condition.

Syntocinon nasal spray will be used for intranasal administration.

Who Took Part

Enrollment: 31 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: Age between 18 and 30 years. Normal or adjusted-to-normal vision (with glasses or lenses).

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: psychiatric disorder; neurological disorder (e.g. epilepsy, migraine); color blindness.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

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, care provider, investigator and outcomes assessor.

It started in 2016-11-21 with completion listed for 2017-05-30.

It ran at 1 site in Belgium.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: social salience frequency-tagging FPVS (time frame: random: 30-70 minutes after nasal spray). Oddball face detection FPVS paradigm (time frame: random: 30-70 minutes after nasal spray). Oddball identity discrimination FPVS paradigm (time frame: random: 30-70 minutes after nasal spray).

It also tracked 6 secondary outcomes, for example Emotion recognition: accuracy on the Palermo Matching task (65 items), resting state EEG, Social responsiveness: Social Responsiveness Scale (SRS), Social phobia: Social Phobia Inventory (SPIN), Attachment: State Adult Attachment Measure (SAAM) and Mood: Positive And Negative Affect Schedule (PANAS).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 31 people.

Its size is small, so on its own it can only give an early look.

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.