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Oxytocin Effects on the Prosocial Learning

Plain-language guide to NCT04105140: not phased randomized trial of Oxytocin, 90 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04105140
Phase
not phased
Status
completed
Start
2018-01-01
Completion (planned or actual)
2018-08-10
Participants
90 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Oxytocin.

It had two arms (groups): male oxytocin group (experimental) and male placebo group (placebo comparator).

Male subjects with oxytocin treatment.

Male subjects with placebo treatment.

The registry classes the interventions as drug.

More on the Plan

In a double-blind, within-subject, placebo controlled design, investigators plan to investigate the effect of oxytocin treatment on prosocial learning.

Before the self-administration, participants need to finish several questionnaires including IRI, AAS, BASBIS, SPSRQ, SES, PTM, STAI, BDI, ASQ and PNAS.

They would finish the PANAS again before the scanning.

Participants are informed that they perform the reward learning task either for themselves, another (unknown) person or no one (control).

Who Took Part

The registry lists 90 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: Without past or current psychiatric or neurological disorders.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: history of head injury; medical or psychiatric illness.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

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 2018-01-01 with completion listed for 2018-08-10.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Neural processing during feedback based on prosocial learning assessed by fMRI scanner (time frame: 1 hour).

It also tracked 1 secondary outcome, for example Behavioral learning performance measured by E-prime.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 90 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.