← Human Trials & Peer-Reviewed Studies

Effect of Oxytocin on Masked Facial Expressions: an fMRI Study

Plain-language guide to NCT02183948: early phase 1 randomized trial of Oxytocin, 86 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02183948
Phase
early phase 1
Status
completed
Start
2014-06
Completion (planned or actual)
2014-12
Participants
86 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Facial Expressions
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this early phase 1 trial, researchers set out to test Oxytocin.

The purpose is to test whether oxytocin has an effect on masked facial expressions.

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

Nasal spray.

Nasal spray.

The registry classes the interventions as drug.

More on the Plan

Using a backward masking procedure and functional magnetic resonance imaging, the researchers investigated the modulatory effects of intranasal OXT on the processing of sub-liminally presented emotional faces.

To ensure attentional processing of the faces subjects were required to perform a simple gender decision task in the scanner and a recognition memory task afterwards.

All subjects were additionally assessed for their state and trait anxiety and depression as well as empathy.

For the analysis, the researchers will use matlab, SPM and SPSS to conduct structural ROI analysis and two Sample t test.

Who Took Part

The registry lists 86 actual participants took part.

It was open to people of any sex aged from 18 years up to 29 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Healthy subjects, no smoke or drink alcohol, coffee or other stimulants during the day before Experiment.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

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

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.

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 2014-06 with completion listed for 2014-12.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Number of participants with neuro activity to facial expressions (time frame: one week).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 86 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.