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The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)
Plain-language guide to NCT01466127: not phased randomized trial of Oxytocin, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01466127
- Phase
- not phased
- Status
- completed
- Start
- 2011-10
- Completion (planned or actual)
- 2014-05
- Participants
- 60 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Posttraumatic Stress Disorder
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Oxytocin.
The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking oxytocin.
Oxytocin is a hormone made naturally in the body.
The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes.
It had two arms (groups): Placebo (placebo comparator) and Oxytocin (experimental).
Matched nasal spray placebo.
Liquid intranasal oxytocin administered in a nasal spray.
The registry classes the interventions as drug.
Who Took Part
The registry lists 60 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Men or women 18 to 65 years of age. Score in study range on the Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI). No current Axis I Diagnostic and Statistical Manual-IV (DSM) excluded diagnoses as determined by the Structured Clinical Interview DSM (SCID) completed within the past 4 months. Must be able and willing to understand study procedures and return to the clinic on two separate consecutive days for the fear-conditioning procedures. Subjects must be able to give informed consent and be willing and able to comply with study procedures.
The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: presence of a current dsm-iv axis i diagnosis as measured by the scid; use of supplemental hormones (birth control, estrogen, testosterone, prednisone, etc) or narcotics; pregnant or lactating women.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
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 2011-10 with completion listed for 2014-05.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Differential Skin Conductance Response (SCR) During the First Two Extinction Trials (time frame: Day 2 of Conditioning (1 day post Day 1 of Conditioning)).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 60 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.