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Oxytocin Effect on Attentional Bias Towards Emotional Expression Faces in Individuals With High and Low Autistic Traits: A Functional Magnetic Resonance Imaging (fMRI) Study

Plain-language guide to NCT02741063: early phase 1 randomized trial of Oxytocin, 120 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02741063
Phase
early phase 1
Status
status unknown
Start
2016-05
Completion (planned or actual)
2019-06
Participants
120 (estimated)
Design
randomized, double-blind, prevention
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.

To investigate whether oxytocin alter attentional bias towards emotional expression faces in individuals with high and low autistic traits, and the brain mechanism of this effect.

It had four arms (groups): high autistic and oxytocin group (experimental), low autistic and oxytocin group (experimental), high autistic and placebo group (placebo comparator) and low autistic and placebo group (placebo comparator).

Subject with high ASQ scores will receive oxytocin treatment.

Subject with low ASQ scores will receive oxytocin treatment.

Subject with high ASQ scores will receive placebo treatment.

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 120 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: Healthy subjects without past or current psychiatric or neurological disorders.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: history of head injury;; medical or psychiatric illness.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2016-05 with completion listed for 2019-06.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): attentional bias toward emotional expression faces (time frame: 1 hour).

It also tracked 1 secondary outcome, for example brain activity during RSVP task.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 120 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.