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Effects of Intranasal Oxytocin on Striatal Functional Connectivity
Plain-language guide to NCT03128203: not phased randomized trial of Oxytocin, 135 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03128203
- Phase
- not phased
- Status
- completed
- Start
- 2016-09
- Completion (planned or actual)
- 2017-02
- Participants
- 135 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Healthy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Oxytocin.
It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
In a double-blind, between-subject, placebo controlled design, investigators plan to investigate the effects of oxytocin treatment on resting-state functional connectivity.
Subject will receive either intranasal oxytocin or placebo administration and go through a seven-minute resting-state scan in MRI scanner to test whether oxytocin changes functional connectivity in the brain.
Trait anxiety and mood questionnaires will be administered as control variables.
Who Took Part
Enrollment: 135 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
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.
The Oxytocin group and the comparison group ran side by side rather than switching.
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 2016-09 with completion listed for 2017-02.
It ran at 1 site in China.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Striatal functional connectivity alterations after drug administration (time frame: 45 minutes after drug administration).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 135 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.