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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.