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Dose-dependent Effects of Oxytocin on the Amygdala and Reward System
Plain-language guide to NCT03846739: phase 1 randomized trial of Oxytocin, 92 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03846739
- Phase
- phase 1
- Status
- completed
- Start
- 2017-04-03
- Completion (planned or actual)
- 2018-12-31
- Participants
- 92 (actual)
- Design
- randomized, triple-blind, basic_science
- Conditions studied
- Healthy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Oxytocin.
It had three arms (groups): one (active comparator), one (active comparator) and one (active comparator).
The registry classes the interventions as drug.
More on the Plan
Results will be discussed in comparison to a previous study of OXT kinetics in men.
Who Took Part
The registry lists 92 actual participants took part.
It was open to women only aged from 18 years up to 40 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy female volunteers.
The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: current psychiatric or physical illness; hormonal contraception; psychoactive medication.
How the Study Was Run
The set-up was randomized, crossover and triple-blind.
Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.
Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.
As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2017-04-03 with completion listed for 2018-12-31.
It ran at 1 site in Germany.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala (time frame: 45 min after nasal spray administration). Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in striatal regions (putamen, nucleus accumbens, caudate, pallidum) (time frame: 45 min after nasal spray administration).
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Oxytocin in 92 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.