Neural Correlates of Empathogenic and Affiliative Actions of Oxytocin

What Was Tested

This registered early phase 1 trial tested Oxytocin.

Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin has prosocial effects.

However, the neural substrates of these effects are still unclear.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 23 actual participants took part.

It was open to men only aged from 18 years up to 60 years.

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

Examples of who could join: Healthy male volunteers. In a heterosexual relationship.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: current or past psychiatric disease; current or past physical illness; psychoactive medication.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

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

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

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

It started in 2012-08 with completion listed for 2013-08.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Empathy ratings and their neural correlates (time frame: About one hour after the intranasal administration of oxytocin).

It also tracked 1 secondary outcome, for example Neural correlates of pair-bonding.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 23 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.