Temporal Dynamics and Pharmacokinetics of Intranasally Administered Oxytocin

What Was Tested

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

It had six arms (groups): one (active comparator), one (active comparator), one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 116 actual participants took part.

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: Healthy male 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

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

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

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 2014-09 with completion listed for 2015-12.

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 signal in the amygdala (time frame: 45min after nasal spray administration).

It also tracked 6 secondary outcomes, for example Ratings of emotional faces, Questionnaire measurement of mood (PANAS), Questionnaire measurement of anxiety (STAI), Saliva oxytocin concentrations, Plasma oxytocin concentrations and Modulatory effects of autistic like traits on neural and behavioral outcome measures.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 116 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.