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The Interaction Between Oxytocin and Serotonin

Plain-language guide to NCT03577457: not phased randomized trial of Oxytocin, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03577457
Phase
not phased
Status
status unknown
Start
2018-02-01
Completion (planned or actual)
2019-06-20
Participants
100 (estimated)
Design
randomized, double-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Oxytocin.

It had four arms (groups): male oxytocin and ATD group (experimental), male oxytocin and placebo group (experimental), male placebo and ATD group (experimental) and male placebo group (placebo comparator).

Male subjects receiving oxytocin and ATD treatment.

Male subjects receiving oxytocin and ATD-placebo treatment.

Male subjects receiving oxytocin placebo and ATD treatment.

The registry classes the interventions as drug.

More on the Plan

Serotonin and oxytocin have been proved to play an important role in social reward processing and decision making in human.

The social-reward related neural activity and behavior will be assessed by a series of social reward task in and out of fMRI scanner and the decision making will be assessed by reversal learning task, ultimatum game (UG) and loss aversion task.

The interaction between serotonin and oxytocin on brain networks will also be tested by resting state.

Who Took Part

100 planned participants were the target.

It was open to men only aged from 18 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 disorders.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: history of head injury;; medical or psychiatric illness; high blood pressure, general cardio-vascular alterations.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant and investigator.

It started in 2018-02-01 with completion listed for 2019-06-20.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Changes in brain neural activity during the social reward processing as assessed via fMRI. Changes in the resting state as assessed via fMRI.

It also tracked 3 secondary outcomes, for example Associations with Personalities of subjects, Behavioral performance in decision making task and Behavioral performance in social reward related task.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 100 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.