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Trait Anxiety and Defensive Networks

Plain-language guide to NCT02682888: not phased randomized trial of Oxytocin, 131 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02682888
Phase
not phased
Status
completed
Start
2015-12-08
Completion (planned or actual)
2021-08-19
Participants
131 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

To examine the association between trait and defensive network connectivity and the modulatory effect of oxytocin on it.

It had four arms (groups): high trait anxiety group (experimental), low trait anxiety group (experimental), oxytocin group (experimental) and placebo control group (placebo comparator).

Experiment 1: identified according to scores of the trait anxiety scale.

Experiment 1: identified according to scores of the trait anxiety scale.

Experiment 2: intranasal administration of oxytocin.

The registry classes the interventions as behavioral and drug.

More on the Plan

Individuals with high trait anxiety show stable anxiety proneness even in the absence of real threat, which could be a result of intrinsic hyper-connectivity in the defensive systems.

In the present study, healthy subjects' trait anxiety levels will be assessed by the sub-trait inventory of the State-Trait Anxiety Inventory.

Who Took Part

131 actual participants took part.

It was open to people of any sex aged from 18 years up to 35 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 1 inclusion and 1 exclusion criteria; among the exclusions: females should not be pregnant or during menstruation.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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 2015-12-08 with completion listed for 2021-08-19.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: the resting state functional connectivity changes in the defensive network (time frame: one day).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 131 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.