Study of the Effects of Oxytocin on Attentional Bias and Startle in PTSD

What Was Tested

In this early phase 1 trial, researchers set out to test Oxytocin.

It had two arms (groups): Immediate Oxytocin (experimental) and Delayed Oxytocin (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Service canine companionship and oxytocin (OT) appear to be on parallel tracks as novel candidate PTSD treatments or treatment enhancers.

A growing literature exploring the role(s) of the OT system in PTSD now includes a number of encouraging findings.

These findings align with findings in healthy persons.

OT also attenuates startle in healthy persons, attenuates amygdala responses to fear-inducing stimuli, and inhibits the stress-responsive release of cortisol.

Who Took Part

The registry lists 17 actual participants took part.

It was open to men only aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: US military Veteran. Current posttraumatic stress disorder.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder; active drug or alcohol use disorder within past 90 days; currently participating in a clinical drug trial.

How the Study Was Run

The set-up was randomized, crossover and triple-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.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2017-07-10 with completion listed for 2021-06-09.

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: Change in attentional bias (time frame: 1-2 weeks). Change in startle response -heart rate (time frame: 1-2 weeks).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 17 people.

Its size is small, so on its own it can only give an early look.

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.