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The Interaction Between Oxytocin and Serotonin

Plain-language guide to NCT03426176: not phased randomized trial of Oxytocin, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03426176
Phase
not phased
Status
status unknown
Start
2018-02-01
Completion (planned or actual)
2019-06-15
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

Evidence is emerging that both systems interact in this domain.

To control for potential effects of pre-medication personality traits as well as effects of medicines on mood, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of mood.

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: Health 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

The set-up was randomized, parallel-group and double-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 and investigator.

It started in 2018-02-01 with completion listed for 2019-06-15.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Neural processing during the emotion processing as assessed via fMRI (time frame: 6h after treatment). Neural processing during the resting state as assessed via fMRI (time frame: 6h after treatment).

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.