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Oral Oxytocin's Effects on Attention Control

Plain-language guide to NCT04493515: not phased randomized trial of Oxytocin, 80 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04493515
Phase
not phased
Status
status unknown
Start
2020-07-28
Completion (planned or actual)
2020-12-31
Participants
80 (estimated)
Design
randomized, triple-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Oxytocin.

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

The registry classes the interventions as drug.

More on the Plan

Numerous studies have reported the effect of intranasally administered oxytocin on attentional processing including stimulus-driven bottom-up processing and top-down goal-directed inhibitory control.

However, it is unclear whether the functional effects are mediated by the peptide directly entering the brain or indirectly via raising peripheral concentrations.

This paradigm uses social (happy, sad, angry, fear, and neutral faces) as well as non-social (oval shapes) stimuli to explore social- and emotion-specific effects of orally administered oxytocin.

Who Took Part

80 planned participants were the target.

It was open to men only aged from 18 years up to 30 years.

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

Examples of who could join: Male, healthy participants.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: previous or current medical, psychiatric, neurological disorder; regular medication; use of any psychoactive substances in the 24 hours before experiment.

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.

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, investigator and outcomes assessor.

It started in 2020-07-28 with completion listed for 2020-12-31.

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 on saccade/antisaccade latencies towards social (facial) versus non-social (shape) stimuli (time frame: 45 minutes - 100 minutes after treatment). Effect of oral oxytocin administration on error rates of saccade/antisaccade for social (facial) versus non-social (shape) stimuli (time frame: 45 minutes - 100 minutes after treatment).

It also tracked 2 secondary outcomes, for example Emotion-specific effects of oral oxytocin administration on saccade/antisaccade latencies towards the separate facial emotions and Emotion-specific effects of oral oxytocin administration on saccade/antisaccade error rates for the separate facial emotions.

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.

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.