Effects of Oxytocin on Cognitive and Reactive Fear

What Was Tested

The trial (phase 1) is built around Oxytocin.

The study examines the (sub)regional specificity of anxiolytic oxytocin (OXT) effects on emotional face processing and reactive and cognitive fear.

Preliminary data indicate that the Receptor for Advanced Glycation End Products (RAGE) may regulate oxytocin transport into the brain.

Thus, the study aims to replicate previous observations of oxytocin effects on the processing of fearful faces in the centro-medial amygdala and to assess whether a RAGE polymorphism (-374 T/A: rs1800624; TT vs.

It had two arms (groups): RAGE polymorphism (TT) (experimental) and RAGE polymorphism (TA/AA) (experimental).

30 participants with the RAGE polymorphism (-374 T/A: rs1800624; TT) will be selected and scanned twice.

30 participants with the RAGE polymorphism (-374 T/A: rs1800624; TA/AA) will be selected and scanned twice.

The registry classes the interventions as drug.

More on the Plan

Furthermore, participants will be pre-stratified depending on RAGE polymorphisms to elucidate possible RAGE-related differential OXT effects.

Who Took Part

Enrollment: 60 planned participants were the target.

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: RAGE polymorphism (-374 T/A: rs1800624; TT vs. TA/AA). Healthy male volunteers.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: current psychiatric illness; current psychiatric medication or psychotherapy; MRI contraindication (e.g. metal in body, claustrophobia).

How the Study Was Run

Design: randomized, crossover and double-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

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 2019-12-13 with completion listed for 2021-05.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Neural substrates of emotion processing, measured via blood-oxygen-level dependent (BOLD) signal in the amygdala and striatum (time frame: 30 minutes after nasal spray administration). Neural responses in the flight initiation distance (FID) task (time frame: 45 minutes after nasal spray administration). Flight distance and difficulty ratings in the flight initiation distance (FID) task (time frame: 45 minutes after nasal spray administration).

It also tracked 2 secondary outcomes, for example Oxytocin concentration in blood plasma and Concentration of receptor for advanced glycation endproducts (extracellular domain) in blood plasma.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.