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The Neural Basis of Oxytocin's Effects on Empathy

Plain-language guide to NCT03084029: early phase 1 randomized trial of Oxytocin, 72 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03084029
Phase
early phase 1
Status
completed
Start
2016-01
Completion (planned or actual)
2017-06
Participants
72 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered early phase 1 trial tested Oxytocin.

The main focus of this study is to examine oxytocin effects on behavioral and neural indices of empathy processing.

It had four arms (groups): male participants - oxytocin nasal spray (experimental), female participants - oxytocin nasal spray (experimental), male participants - placebo nasal spray (placebo comparator) and female participants - placebo nasal spray (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The present study aims at replicating previous findings on OXT on empathy as well as to determine the neural basis of these effects.

Before the administration of treatment, validated questionnaires assessing potential confounding variables, such as depression (Becks Depression Inventory (BDI)) or mood (Positive And Negative Affect Scale (PANAS)) will be administered to the subjects.

Who Took Part

The registry lists 72 actual participants took part.

It was open to people of any sex 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 past or current psychiatric or neurological disorders. No smoking at least 12 hours before experiment. No alcohol, coffee or other stimulant drinking at least 12 hours before experiment.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: mental implants; uterine cavity operations; use of medication.

How the Study Was Run

The set-up was randomized, factorial and double-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2016-01 with completion listed for 2017-06.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Neural processing of empathy as assessed using fMRI.

It also tracked 1 secondary outcome, for example Behavioral ratings of subjective experienced empathy processing.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 72 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.

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.