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Oxytocin and Emotion Processing
Plain-language guide to NCT02156661: phase 1 randomized trial of Oxytocin, 97 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02156661
- Phase
- phase 1
- Status
- completed
- Start
- 2013-05
- Completion (planned or actual)
- 2014-06
- Participants
- 97 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Healthy Males
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Oxytocin.
The purpose of this study is to determine whether oxytocin influences emotional processing and learning of emotional and social stimuli.
It had two arms (groups): Oxytocin (active comparator) and Placebo (placebo comparator).
Placebo nasal spray.
The registry classes the interventions as drug.
More on the Plan
An effect of OXT on emotion processing and anxiety has been broadly investigated in animal studies.
However, in humans, effects seem more complex.
The rationale of the study is to examine direct effects of OXT to processing and learning of emotional and social values in humans.
Who Took Part
Enrollment: 97 actual participants took part.
It was open to men only aged from 20 years up to 40 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy male volunteers.
The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: current or past psychiatric disease; current or past physical illness; psychoactive medication.
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
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.
The Oxytocin group and the comparison group ran side by side rather than switching.
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, care provider, investigator and outcomes assessor.
It started in 2013-05 with completion listed for 2014-06.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Brain activity (time frame: During emotion processing).
It also tracked 1 secondary outcome, for example Psychophysiological response.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Oxytocin in 97 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.