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Oxytocin and Interpersonal Motor Resonance
Plain-language guide to NCT03010670: phase 4 randomized trial of Oxytocin, 27 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03010670
- Phase
- phase 4
- Status
- completed
- Start
- 2016-01
- Completion (planned or actual)
- 2016-08
- Participants
- 27 (actual)
- Design
- randomized, triple-blind, basic_science
- Conditions studied
- Social Behavior
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Oxytocin.
Among different social cues from the environment, the eyes constitute a very salient source for initiating social interaction or communication.
It had two arms (groups): Oxytocin (OT) spray (experimental) and Placebo (PL) spray (placebo comparator).
The registry classes the interventions as drug and other.
More on the Plan
To investigate the effects of exogenous OT administrations, the investigators adopted a double-blind, within-subjects (cross-over), randomized, placebo-controlled trial.
The investigators will recruit approximately 30 neurotypical young adults males between 18 - 35 years old.
Since a cross-over design is included, subjects will participate in two sessions, separated by one week.
In each session, the non-invasive brain stimulation technique 'transcranial magnetic stimulation' (TMS) will be used at the level of the primary motor cortex to obtain an end-state measure of unconscious 'mirror-motor mapping' or IMR.
Who Took Part
The registry lists 27 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: Young adults (between 18 - 35 y/o).
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: any neuro(psycho)logical / psychiatric illness; motor dysfunctions of the hands / arms.
How the Study Was Run
It was run as a randomized, crossover and triple-blind study.
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 2016-01 with completion listed for 2016-08.
It ran at 1 site in Belgium.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Assessment of interpersonal motor resonance (IMR) (time frame: 30 minutes).
It also tracked 4 secondary outcomes, for example State Adult Attachment Measure (SAAM) (sub)scores, Social Responsiveness Scale (SRS) (sub)scores, Spontaneous gaze behavior and Participants' mood.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Oxytocin in 27 people.
Its size is small, so on its own it can only give an early look.
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.