Oxytocin, Trauma Disclosure and Intrusions

What Was Tested

The trial (phase 1) is built around Oxytocin.

Severe traumatic experiences such as falling victim to assault, torture, or rape have deleterious effects.

Clinical manifestations include intrusions, avoidance behavior, and hyperarousal, which are associated, at a circuit level, with hyperfunction of the amygdala and hypofunction of prefrontal cortex (PFC) subregions.

It had three arms (groups): Oxytocin (6 days) (active comparator), Oxytocin (3 days) (active comparator) and Placebo (placebo comparator).

Placebo nasal spray for six days.

The registry classes the interventions as drug.

More on the Plan

Participants will be exposed to an experimental trauma (i.e. a highly aversive movie) at days 1 and 4 of the study.

After the first experimental trauma and after the first functional magnetic resonance imaging (fMRI) measurement, the participants will receive intranasal OXT or placebo in three different groups (1.

OXT for six days, 2.

OXT for three days and then placebo for three days, 3. placebo for six days).

Who Took Part

The registry lists 70 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy female volunteers.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: current or past psychiatric disease; current or past physical illness; psychoactive medication.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2016-06-01 with completion listed for 2017-03-18.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Total number of intrusions following the first trauma movie exposure (time frame: Three days following the first trauma movie exposure). Total number of intrusions following the second trauma movie exposure (time frame: Three days following the second trauma movie exposure). Neural responses to emotional faces in the amygdala (time frame: Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min).

It also tracked 6 secondary outcomes, for example Changes in pupil diameter in response to the trauma movie, Changes in skin conductance level in response to the trauma movie, Changes in respiration rate in response to the trauma movie, Salivary oxytocin concentrations, Salivary cortisol concentrations and Questionnaire measurement of mood (PANAS).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 70 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.