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Effects of Oxytocin and Lorazepam on Fear-related Intra-amygdalar Activity
Plain-language guide to NCT03829839: phase 1 randomized trial of Oxytocin, 120 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03829839
- Phase
- phase 1
- Status
- completed
- Start
- 2016-03-03
- Completion (planned or actual)
- 2017-08-16
- Participants
- 120 (actual)
- Design
- randomized, triple-blind, basic_science
- Conditions studied
- Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of Drugs
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Oxytocin.
Importantly, the long-term use of benzodiazepines may produce dependence and withdrawal.
Therefore, there is considerable scientific and public interest in identifying new anxiolytic agents.
It had two arms (groups): one (active comparator) and one (active comparator).
The registry classes the interventions as drug.
Who Took Part
120 actual participants took part.
It was open to men 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 male volunteers.
The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: current or past psychiatric illness; current or past physical illness; psychoactive medication.
How the Study Was Run
It was run as a randomized, parallel-group and triple-blind study.
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.
Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2016-03-03 with completion listed for 2017-08-16.
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 responses to emotional faces in the amygdala subregions (time frame: Neural activations with be measured with 7 Tesla fMRI in an emotional face matching task that lasts 20 mins).
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Oxytocin in 120 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.