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Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety
Plain-language guide to NCT01551303: not phased randomized trial of Oxytocin, 47 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01551303
- Phase
- not phased
- Status
- completed
- Start
- 2009-02
- Completion (planned or actual)
- 2012-12
- Participants
- 47 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Social Intelligence
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Oxytocin.
The purpose of this study is to learn more about how emotional processing may be affected by a hormone called oxytocin.
Oxytocin is a hormone that occurs naturally in the body, and may play an important role in the way that the brain perceives information.
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.
More on the Plan
Extensive research has been conducted to examine cognitive styles in anxiety disorders that may contribute to the psychopathology of these disorders.
One of the most consistent findings has been that anxious subjects attend preferentially to threatening stimuli.
Related to an attentional bias is the concept of a perceptual bias, from which people with anxiety disorders may be more perceptive to negative emotional cues.
For example, Duncan and Barrett (2007) found a negative correlation between objective awareness of quickly presented faces depicting fear and extraversion.
Who Took Part
Enrollment: 47 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: Age 18 to 65. Subjects must be able to give informed consent and be willing and able to comply with study procedures.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: pregnant or lactating women; subjects currently taking hormones, such as estrogen; known hypersensitivity to oxytocin or to any of the excipients of syntocinon nasal spray.
How the Study Was Run
Design: randomized, parallel-group 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.
The Oxytocin group and the comparison group ran side by side rather than switching.
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 2009-02 with completion listed for 2012-12.
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: Affective Ratings in Affective Learning Task (time frame: 30 minutes after drug administration).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 47 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.