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Sex- and Context-dependent Effects of Oxytocin on Social Reward Processing
Plain-language guide to NCT03085628: not phased randomized trial of Oxytocin, 252 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03085628
- Phase
- not phased
- Status
- status unknown
- Start
- 2016-07
- Completion (planned or actual)
- 2018-08
- Participants
- 252 (estimated)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Mental Health Wellness 1; Social Behavior; Emotion
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Oxytocin.
The aim of the present study is to examine whether the neuropeptide oxytocin (OXT) influences social reward processing and whether the effects are context- and sex-dependent.
It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).
Oxytoxin nasal spray.
Placebo nasal spray.
The registry classes the interventions as drug.
More on the Plan
During the social reward task subjects will be asked to rate the valence and arousal of emotional pictures in three different conditions: alone, share with a stranger and share with their friend.
Before treatment, subjects will complete a range of validated questionnaires to control for potential confounders, such as level of depression (assessed using the BDI) and to explore associations between relevant personality factors and treatment effects, such as adult attachment style (assessed using the AAS).
Who Took Part
252 planned participants were the target.
It was open to people of any sex aged from 17 years up to 30 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy subjects without past or current psychiatric or neurological disorder, right-handed, had normal or corrected-to normal vision.
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: self-reported medication use, substance abuse, and presence of medical or psychiatric disorders.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.
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 2016-07 with completion listed for 2018-08.
It ran at 1 site in China.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: fMRI: neural activity during social reward processing (time frame: 45-115 minutes after administration). Modulatory effects of sex on fMRI based neural indices during social reward processing (time frame: 45-115 minutes after administration). fMRI: functional connectivity during social reward processing (time frame: 45-115 minutes after administration).
It also tracked 5 secondary outcomes, for example Behavior: arousal ratings during social reward processing, Behavior: valence rating during social reward processing, Modulatory effects of sex on arousal ratings during social reward processing, Modulatory effects of sex on valence ratings during social reward processing and Pre-treatment modulators: attachment style (AAS).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 252 people.
Its status is unknown; 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.