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Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception

Plain-language guide to NCT02238379: early phase 1 randomized trial of Oxytocin, 26 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02238379
Phase
early phase 1
Status
completed
Start
2014-09
Completion (planned or actual)
2015-12
Participants
26 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Social Perception
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

In this early phase 1 trial, researchers set out to test Oxytocin.

The objective of this study is to investigate the effects of oxytocin on social behavior and brain activity using EEG and the event-related potential (ERP) technique.

The value of EEG is its high temporal specificity, enabling precision in the timing of social behavior to be addressed.

In order to elicit social responses in the human brain, a variety of social and emotional visual stimuli will be presented during EEG recording, namely infant and adult faces and houses.

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

Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

The registry classes the interventions as drug and other.

Who Took Part

26 actual participants took part.

It was open to women only aged from 18 years up to 64 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Adults ages 18-64. Good medical health. Ability to understand and speak English.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: medical illnesses: moderate or severe acute or chronic medical illnesses (e.g. cardiac disease, diabetes, epilepsy, influenza); A history of seizures or current use of anticonvulsants; history of head injury with loss of consciousness.

How the Study Was Run

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

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

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

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 2014-09 with completion listed for 2015-12.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Amplitude Social (time frame: Duration of 30 minutes). Amplitude Non-Social (time frame: Duration of 30 minutes). Latency Social (time frame: Duration of 30 minutes).

It also tracked 7 secondary outcomes, for example Depression, Smoking, Anxiety, Stress, Early Experience and Number of Participants Endorsing Substance Use.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 26 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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.