Oxytocin's Effect on Socioemotional Aging

What Was Tested

The trial (not phased) is built around Oxytocin.

This study will investigate the extent to which intranasal oxytocin affects changes in social decision making and evaluations of others.

Research on the effects of oxytocin in aging is very scarce; therefore, the purpose of this research project is to determine the effects of oxytocin on socioemotional aging.

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

The registry classes the interventions as drug.

More on the Plan

Participants in this study will be randomly assigned (much like flipping a coin) to receive either a single administration of oxytocin or a placebo (a substance that looks like the oxytocin but does not have any active drug).

Neither participants nor the investigator will know to which condition each participant is assigned.

Prior to being enrolled into the study a screening to determine eligibility will be conducted.

Once the screening visit is completed and it has been determined that subjects can be randomized into the study, an appointment will be scheduled for the full study visit.

Who Took Part

106 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Between the ages of 18-30 years or 63-85 years.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: pregnant or possibly pregnant; currently on vasoconstrictors, pseudoephedrine or antidiuretic medication; large pieces of metal in the body, particularly in the face or neck.

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2013-07 with completion listed for 2014-09.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Extent of Trust Behavior (time frame: 45 minutes after drug/placebo administration).

It also tracked 2 secondary outcomes, for example Meta-Mood and Functional Connectivity (Resting fMRI).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 106 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.