Inhaled Oxytocin and HPA Axis Reactivity

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

Mothers who were enrolled in the Mood, Mother and Infant study will be eligible to participate in the 6-year follow-up maternal visit.

Following administration of the study drug, women will participate in the Trier Social Stress Test (TSST), and blood samples will be collected to quantify HPA axis reactivity.

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

Participants block randomized to Oxytocin intranasal spray by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).

Participants block randomized to placebo Intranasal spray with all equivalent ingredients except oxytocin. Blocks will be stratified by risk status at enrollment in the Mood, Mother and Infant (MMI) study and as verified by structured clinical diagnostic interview (no history of depression or anxiety, past depression or anxiety, current depression or anxiety).

The registry classes the interventions as drug.

More on the Plan

The Mood, Mother and Infant Study is a prospective observational cohort study that began enrollment in May of 2013.

Women were recruited in the 3rd trimester of pregnancy and followed prospectively through 12 months postpartum.

The trial described here is a randomized controlled trial embedded within the Psychobiology of Resilience study.

The Investigational Drug Service (IDS) will use a random number generator to prepare a randomization table.

Who Took Part

109 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 0 inclusion and 9 exclusion criteria; among the exclusions: singleton pregnancy;; intention to breastfeed (due to the centrality of breastfeeding to the oxytocin assessment);; ability to communicate in english.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

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

It started in 2019-02-07 with completion listed for 2023-07-25.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Mean Cortisol (CRT) During Trier Social Stress Test (TSST) (time frame: -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes).

It also tracked 4 secondary outcomes, for example Mean Adrenocorticotropic Hormone (ACTH ) During TSST, Lagged Association Between ACTH and CRT During the TSST, Changes in High Frequency Respiratory Sinus Arrhythmia Power, an Index of Parasympathetic Activity, During the TSST and Changes in Pre-ejection Period, an Index of Sympathetic Activity, During the TSST.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 109 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.