Oral Oxytocin Modulation of Responses to Emotional Stimuli

What Was Tested

This registered not phased trial tested Oxytocin.

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

Placebo orally (identical ingredients, except the active agent).

The registry classes the interventions as drug.

More on the Plan

A number of previous studies have reported both neural and social cognition effects of intranasally administered oxytocin, although it is unclear whether functional effects are mediated by the peptide directly entering the brain or indirectly via raising peripheral concentrations.

After the tasks, subjects will be required to rate their valence, intensity and arousal response to the same emotional face and scene stimuli which were presented during MRI acquisition.

Blood samples will be taken before and 30 min after the oral treatment interventions to assess oxytocin blood concentrations.

Who Took Part

80 planned participants were the target.

It was open to men only aged from 17 years up to 32 years.

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

Examples of who could join: Healthy subjects without any past or present psychiatric or neurological disorders.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: history of brain injury; head trauma; substance abuse.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

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, investigator and outcomes assessor.

It started in 2020-02-20 with completion listed for 2020-12-01.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Effect of oral oxytocin administration of oxytocin on neural responses to positive and negative valence emotional faces, as assessed by task fMRI (time frame: 45-90 minutes after treatment). Effect of oral oxytocin administration on neural responses to positive and negative valence scenes, as assessed by fMRI (time frame: 45-90 minutes after treatment). Effect of oral oxytocin administration on behavioral ratings of face emotion and scene stimuli (time frame: 45-115 minutes after treatment).

It also tracked 3 secondary outcomes, for example Correlations between neural responses/functional connectivity changes and post-scan behavioral ratings.

What This Means in Plain Language

Put simply, this is a not phased, 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.