The Effect of Oxytocin on the Consolidation of Trauma-Associated Memories

What Was Tested

This registered not phased trial tested Oxytocin.

The purpose of the study is to examine whether oxytocin and certain polygenic risk scores affect the development of intrusive memories, a cardinal symptom of PTSD.

It had two arms (groups): Oxytocin and trauma film paradigm (experimental) and Placebo and trauma film paradigm (placebo comparator).

Intervention: Drug: Oxytocin nasal spray.

Intervention: Drug: Placebos.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 217 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Healthy female volunteers. German on a native level.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: former or present disorder according to the diagnostic and statistical manual of mental disorders 5 (dsm-5); any physical illnesses; any medication intake (except oral contraceptive).

How the Study Was Run

The set-up was randomized, factorial and triple-blind.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2019-03-06 with completion listed for 2020-12-31.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change of Intrusive Memories in the following four days after the intervention (time frame: four consecutive days).

It also tracked 3 secondary outcomes, for example Noradrenergic System (measured with salivary alpha-amylase - u/ml), Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L) and Polygenic Risk Score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 217 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.