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Oxytocin and Attachment-related Interpretation Bias
Plain-language guide to NCT02737254: phase 4 randomized trial of Oxytocin, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02737254
- Phase
- phase 4
- Status
- completed
- Start
- 2016-03
- Completion (planned or actual)
- 2016-10
- Participants
- 100 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Trust
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Oxytocin.
The purpose of this study is to investigate the effects of oxytocin and a cognitive bias modification (CBM) procedure on children's trust in their mother.
It had four arms (groups): one (experimental), one (active comparator), Oxytocin and Neutral CBM training (active comparator) and Placebo and Neutral CBM training (placebo comparator).
The registry classes the interventions as drug and other.
More on the Plan
Oxytocin is a neuropeptide that is involved in human attachment and bonding.
Pre- and post-intervention children's trust in mother, support seeking behavior and interpretation of maternal behavior is assessed.
Moreover, possible oxytocin side-effects will be monitored.
Who Took Part
Enrollment: 100 actual participants took part.
It was open to people of any sex aged from 8 years up to 13 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Between 8 and 13 years old. Mother can also participate.
The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: known oxytocin allergy; currently using medication; kidney or cardial condition.
How the Study Was Run
The set-up was randomized, factorial and double-blind.
Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.
Those kept unaware of assignments: participant and investigator.
It started in 2016-03 with completion listed for 2016-10.
It ran at 1 site in Belgium.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in trust in mother (time frame: Immediately before and immediately after intervention).
It also tracked 5 secondary outcomes, for example Change in attachment-related behavior towards mother, Interpretation speed of positive maternal behavior and Interpretation speed of negative maternal behavior.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Oxytocin in 100 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.