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The Influence of Oxytocin on Automatic Imitation Behaviour in Healthy Adults
Plain-language guide to NCT01767025: phase 3 randomized trial of Oxytocin, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01767025
- Phase
- phase 3
- Status
- completed
- Start
- 2012-11
- Completion (planned or actual)
- 2012-12
- Participants
- 60 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Healthy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Oxytocin.
In this study, the influence of oxytocin on automatic imitation behaviour is investigated.
Healthy adults will be administered with either oxytocin or a placebo, and will perform an imitation-inhibition task (as a measure of automatic imitation behaviour).
To determine the specificity of the oxytocin effect, an unrelated cognitive task (Stroop task) will also be presented.
It had two arms (groups): Oxytocin (experimental) and Sea water (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 60 actual participants took part.
It was open to men only aged from 18 years up to 40 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: no pacemaker, deep brain stimulation electrodes or other stimulation devices; normal neurological history (no brain operations, migraine, epilepsy, alcoholism; no epilepsy in family.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
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.
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 and investigator.
It started in 2012-11 with completion listed for 2012-12.
It ran at 1 site in Belgium.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): To evaluate the automatic imitation behaviour 45 minutes after drug administration (time frame: 120 minutes).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Oxytocin in 60 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.