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The Role of Oxytocin in the Perception of Faces

Plain-language guide to NCT02443727: early phase 1 randomized trial of Oxytocin, 71 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02443727
Phase
early phase 1
Status
completed
Start
2015-04
Completion (planned or actual)
2015-12
Participants
71 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (early phase 1) is built around Oxytocin.

The main objective of this project is to study whether intranasal oxytocin (OT) affects how young adults perceive and attend to infant and adult faces.

Based on existing research the investigators predict that oxytocin will facilitate the allocation of attentional resources on infant faces (compared to adult faces).

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

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 71 actual participants took part.

It was open to men only aged from 18 years up to 25 years.

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

Examples of who could join: Norma or corrected to norma vision. Participants are non parents. Able to provide written informed consent and to comply with all study procedures.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: dementia or severe cognitive disorders; endocrine disease or malignancy; nasal obstruction or upper-respiratory tract infection.

How the Study Was Run

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

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

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

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 and investigator.

It started in 2015-04 with completion listed for 2015-12.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Functional Magnetic Resonance Imaging (fMRI) Data (time frame: 45 minutes after OT manipulation). Eye movements data (time frame: 45 minutes after OT manipulation).

It also tracked 2 secondary outcomes, for example Implicit Attitudes toward infants and Theory of mind.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 71 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.