Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety

What Was Tested

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

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

The registry classes the interventions as drug.

More on the Plan

In the present study, healthy male subjects' trait anxiety levels will be assessed by the sub-trait inventory of the State-Trait Anxiety Inventory (STAI).

According to subjects' trait anxiety scores, they will be divided into high or low anxiety experimental groups.

Also the brain structure data (T1 and diffusion tensor imaging, DTI) of subjects will be collected.

Who Took Part

147 actual participants took part.

It was open to men only aged from 18 years up to 30 years.

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

Examples of who could join: Healthy adult males. Past or current psychiatric or neurological disorder. FMRI contraindications (e.g. metal implants).

The full record lists 6 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

The Oxytocin group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant and investigator.

It started in 2017-03-03 with completion listed for 2018-03-31.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Changes between acute and chronic administration of oxytocin on amygdala activity as assessed by fMRI (time frame: 5 days). Changes between acute and chronic administration of oxytocin on amygdala connectivity as assessed by fMRI (time frame: 5 days).

It also tracked 6 secondary outcomes, for example Interaction of acute and chronic treatment effects with trait anxiety on neural activity, Interaction of acute and chronic treatment effects with trait anxiety on neural connectivity, Effects of oxytocin on arousal ratings of emotional stimuli (acute and changes with chronic treatment), Effects of oxytocin on valence ratings of emotional stimuli (acute and changes with chronic treatment), Interaction of treatment effects on valence ratings with trait anxiety (acute and changes with chronic treatment) and Interaction of treatment effects on arousal ratings with trait anxiety (acute and changes with chronic treatment).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 147 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.