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Oxytocin Modulates Eye Gaze Behavior During Social Processing

Plain-language guide to NCT03293511: not phased randomized trial of Oxytocin, 40 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03293511
Phase
not phased
Status
status unknown
Start
2017-06-09
Completion (planned or actual)
2019-07
Participants
40 (estimated)
Design
randomized, triple-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Oxytocin.

The main aim of the study is to examine whether the effects of intranasal oxytocin on eye-gaze behavior towards social stimuli are modulated via individual differences in trait autism.

It had two arms (groups): Order of administration: oxytocin - placebo (experimental) and Order of administration: placebo - oxytocin (experimental).

The registry classes the interventions as drug.

More on the Plan

Autistic and associated traits will be assessed using the Autism Spectrum Quotient (ASQ), Social Responsibilities Scale (SRS) and the Interpersonal Reactivity Index (IRI).

Within-subject differences in the effects of oxytocin on social eye gazing behaviour will be related to individual differences in autistic traits.

Who Took Part

40 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 any past or present psychiatric or neurological disorders.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: history of brain injury; visual impairments; use of medication.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2017-06-09 with completion listed for 2019-07.

It ran at 2 sites in China (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Global eye gaze characteristic: differences between oxytocin and placebo treatment (time frame: 45-90 minutes after treatment administration). Feature-specific eye gaze characteristics: differences between oxytocin and placebo treatment (time frame: 45-90 minutes after treatment administration).

It also tracked 2 secondary outcomes, for example Global eye gaze characteristic - associations with autism traits and Feature-specific eye gaze characteristics - associations with trait autism.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 40 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.