Effect of Oral Oxytocin on Women's Response 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

PANAS is administered before and after oral administration and after functional magnetic resonance imaging (fMRI) scanning.

After fMRI scanning, subjects will be required to rate valence, intensity, and arousal responses (Likert scale, 1-9 ratings) to the emotional and affective stimuli are presented during fMRI scanning.

Who Took Part

Enrollment: 80 planned participants were the target.

It was open to women 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 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

It was run as a randomized, parallel-group and triple-blind study.

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

The Oxytocin group and the comparison group ran side by side rather than switching.

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 2021-04-01 with completion listed for 2021-11-30.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Changes in blood oxytocin concentrations after oral oxytocin (time frame: Before and 30 minutes after treatment). Effects of oral oxytocin on neural responses to emotional faces assessed by emotional faces processing task fMRI (time frame: 45 minutes after treatment). Effects of oral oxytocin on neural responses to affective scenes assessed by affective scenes processing task fMRI (time frame: 45 minutes after treatment).

It also tracked 14 secondary outcomes, for example The relationship between plasma oxytocin concentrations changes and neural responses to emotional faces stimuli, The relationship between plasma oxytocin concentrations changes and neural responses to affective scenes stimuli, The relationship between plasma oxytocin concentrations changes and behavioral responses to emotional faces stimuli, The relationship between plasma oxytocin concentrations changes and behavioral responses to affective scenes stimuli, Gender differences in plasma oxytocin concentrations changes and Gender differences in neural response to emotional faces stimuli.

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.