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Effects of Intranasal Oxytocin on Functional Brain Network in Resting-state and Tasks

Plain-language guide to NCT03428906: not phased randomized trial of Oxytocin, 34 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03428906
Phase
not phased
Status
completed
Start
2016-05-24
Completion (planned or actual)
2017-04-25
Participants
34 (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.

It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

State anxiety and mood are measured before and after experiment as covariates to be controlled.

Who Took Part

Enrollment: 34 actual participants took part.

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 1 inclusion and 1 exclusion criteria; among the exclusions: with mri contraindications.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2016-05-24 with completion listed for 2017-04-25.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Functional network organization alterations in brain under resting state fMRI after drug administration (time frame: 70~85 minutes after drug administration). Behavior,brain activities and representation patterns in the emotional judgement task after drug administration (time frame: 60~75 minutes after drug administration). Behavior, dynamics brain activities and networks in the model-based decision making task after drug administration (time frame: 35~60 minutes after drug administration).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 34 people.

Its size is small, so on its own it can only give an early look.

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.