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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.