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Oxytocin and Social Cognition

Plain-language guide to NCT01606462: phase 1 randomized trial of Oxytocin, 153 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01606462
Phase
phase 1
Status
completed
Start
2011-06
Completion (planned or actual)
2013-06
Participants
153 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Healthy Male Volunteers
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1) is built around Oxytocin.

The purpose of this study is to determine whether oxytocin influences memory of social stimuli and reaction to social stimuli.

Furthermore the investigators explore the effect of oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social stimuli.

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

The registry classes the interventions as drug.

More on the Plan

However, this interpretation is challenged by observations that OXT also promotes envy and schadenfreude (gloating), ethno-centrism (including prejudice, xenophobia, and racial bias), and defensive aggression towards outsiders.the researchers investigate the neural correlates of emotion perception and subsequent memory effects of aversive and neutral stimuli.

Tthe oxytocin effect on personal space is questioned.

Additionally the effect of OXTR polymorphism regarding behavioral and neural response is explored.

Who Took Part

Enrollment: 153 actual participants took part.

It was open to men only aged from 20 years up to 35 years.

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

Examples of who could join: Healthy male volunteers.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: current or past psychiatric disease; current or past physical illness; psychoactive medication.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2011-06 with completion listed for 2013-06.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: neural correlates of emotion perception and subsequent memory effects of aversive and neutral stimuli (time frame: two years).

It also tracked 2 secondary outcomes, for example the effect of oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social stimuli and The oxytocin effect on social behavior e.g. personal space is questioned.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 153 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.