← Human Trials & Peer-Reviewed Studies
Oxytocin, Emotions and Mirror Neurons
Plain-language guide to NCT02228031: early phase 1 randomized trial of Oxytocin, 44 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02228031
- Phase
- early phase 1
- Status
- completed
- Start
- 2014-10
- Completion (planned or actual)
- 2016-08
- Participants
- 44 (actual)
- Design
- randomized, triple-blind, basic_science
- Conditions studied
- Social Cognition; Expressed Emotion
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered early phase 1 trial tested Oxytocin.
The purpose of this project is to investigate the possible effect of intranasally administered Oxytocin (OT) on specific mirror neuron areas in human brain.
The mirror neuron system (MNS) is thought to be involved in action perception and understanding, and may also underlie more complex cognitive processes such as imitation.
The researchers will use electroencephalographic (EEG) investigations to examine brain activity while participants complete two different tasks, consisting of the observation and imitation of emotional facial expressions (video presented) and the observation and execution of simple grasping actions (live presented), respectively.
It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).
The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.
The registry classes the interventions as drug and other.
Who Took Part
The registry lists 44 actual participants took part.
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: Sufficient spoken English so as to be able to complete testing validly and give informed consent.
The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: currently taking any psychotropic or cognition enhancing medication; history of schizophrenia or any other psychotic disorder, including bipolar disorder; family history of psychosis.
How the Study Was Run
Design: randomized, parallel-group and triple-blind.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
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 2014-10 with completion listed for 2016-08.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: EEG mu rhythm suppression (time frame: Before oxytocin/placebo administration and 45 minutes after).
What This Means in Plain Language
Put simply, this is a early phase 1, randomized trial of Oxytocin in 44 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.