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Influence of Oxytocin on Approach-avoidance Tendencies to Social and Non-social Stimuli
Plain-language guide to NCT04443647: not phased randomized trial of Oxytocin, 64 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04443647
- Phase
- not phased
- Status
- completed
- Start
- 2018-12-15
- Completion (planned or actual)
- 2020-01-30
- Participants
- 64 (actual)
- Design
- randomized, triple-blind, basic_science
- Conditions studied
- Basic Science
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Oxytocin.
To obtain a behavioral measure of approach-avoidance tendencies, participants will be able to control the viewing time of the presented stimuli, by pressing 'up' or 'down' on a keyboard.
During stimulus presentation neurophysiological recordings will be performed to obtain a neural measure of approach-avoidance motivational tendencies, based on electroencephalographic recordings (EEG: frontal alpha asymmetry).
It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
The neuropeptide oxytocin (OT) plays an important role in a wide-range of complex social behaviors.
Since the neural substrates underlying 'social' approach and avoidance are not distinct from those underlying 'non-social' approach and avoidance, the GAAO posits that the modulatory effects of OT should not be limited to social behaviors.
In this view, the GAAO puts forward that OT may indeed enhance the attentional salience of many social cues, but not because they are social per se; but because many social stimuli are emotionally-evocative and personally-relevant.
Also electrodermal recordings (skin conductance) will be collected to obtain assessments of sympathetically-driven autonomic arousal.
Who Took Part
The registry lists 64 actual participants took part.
It was open to men only aged from 18 years up to 35 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Age between 18 and 35. Normal or adjusted-to-normal vision (with lenses only). Dutch as mother tongue.
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: age below 18 or above 35; neurological or psychiatric condition (e.g. epilepsy, stroke, concussion), (e.g. anxiety disorder, depression); use of psychotropic medication (e.g. anxiolytics, antidepressants).
How the Study Was Run
Design: 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.
Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2018-12-15 with completion listed for 2020-01-30.
It ran at 1 site in Belgium.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Change in EEG frontal alpha asymmetry after nasal spray administration (time frame: Average over trials, baseline and approximately 30 minutes after nasal spray administration). Change in behavioral approach-avoidance (number of up or down key presses, prolonging or shortening the viewing time towards presented stimuli) (time frame: Average over trials, baseline and approximately 30 minutes after nasal spray administration). Change in skin conductance (type of electrodermal recording) after nasal spray administration (time frame: Average over trials, baseline and approximately 30 minutes after nasal spray administration).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 64 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.