The Biology of Resilience

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

It had six arms (groups): Oxytocin (experimental), Placebo (placebo comparator), Social Support (experimental), No Social Support (placebo comparator) and Female Gender (other).

One primary experimental manipulation is the receipt of intranasal oxytocin vs placebo spray prior to participation in a psychosocial stress protocol.

The comparison condition for receipt of oxytocin is receipt of a saline intranasal spray.

Participants bring a friend to the laboratory who sits with them while they engage in the stress protocol tasks.

The registry classes the interventions as behavioral and drug.

More on the Plan

Historically, most work on the oxytocin system in humans has been tied to reproductive outcomes (e.g., lactation), with more limited work on children and young adults.

The immediate goal of this research is to determine whether oxytocin plays a critical role in determining neuroendocrine, cardiovascular, and subjective responses to stress across age and gender, and to examine the effects of oxytocin in relation to those of social support.

To achieve these goals, experimental research is proposed to examine the effects of exogenously administered (intranasal) oxytocin on psychological and physiological outcomes, under conditions of stress.

The specific aims of this exploratory project are to test the following hypotheses: 1.

Who Took Part

Enrollment: 270 actual participants took part.

It was open to people of any sex aged from 22 years up to 65 years.

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

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: any known medical condition (including mental disorders) or on any type of medication; high levels of social anxiety; high rates of alcohol or drug use.

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2009-02 with completion listed for 2012-04.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Systolic Blood Pressure Change From Baseline to Second Stress Task Experience - Autonomic Stress Response Measure (time frame: within 2 hours of treatment). Difference of Pre-count and Baseline Self-reported Negative Affect (Using Negative Sub-scale of Positive and Negative Affect Schedule (PANAS) Measure) (time frame: 2 hours). Speech Threat and Challenge (time frame: 2 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 270 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.