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Oxytocin and Social Behavior Over the Lifespan
Plain-language guide to NCT00914953: early phase 1 randomized trial of Oxytocin, 41 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00914953
- Phase
- early phase 1
- Status
- completed
- Start
- 2010-02
- Completion (planned or actual)
- 2010-12
- Participants
- 41 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Social Activity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this early phase 1 trial, researchers set out to test Oxytocin.
This study will investigate if intranasal oxytocin (a hormone naturally produced in the body) promotes motivation for, and engagement in, social activities in older adults.
It had 1 arm (groups): oxytocin (experimental).
The registry classes the interventions as drug.
More on the Plan
Using a double-blind and placebo controlled design, this study seeks to determine if a short course of exogenous oxytocin (OT) will induce changes in social activities in residentially housed older adults (OAs) during a 10-day treatment period, and after it ends.
Who Took Part
Enrollment: 41 actual participants took part.
It was open to people of any sex aged from 50 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: non ambulatory; severe psychiatric problems presently or in the recent past; severe medical problems (e.g., cancer, diabetes, advanced heart disease).
How the Study Was Run
It was run as a randomized, single-group and double-blind study.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
Those kept unaware of assignments: participant and investigator.
It started in 2010-02 with completion listed for 2010-12.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
It also tracked 1 secondary outcome, for example Evidence of greater psychological health for treatment condition as compared to control condition.
What This Means in Plain Language
Put simply, this is a early phase 1, randomized trial of Oxytocin in 41 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.