Preventing Postpartum Depression With Intranasal Oxytocin

What Was Tested

The trial (phase 2) is built around Oxytocin.

To this end, the investigators will test the clinical utility of intranasal (IN) oxytocin (OXT) administered to mothers during the first postpartum days.

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

Sub-group of participants receiving oxytocin nasal spray (Syntocinon).

Sub-group of participants receiving placebo nasal spray.

The registry classes the interventions as drug.

More on the Plan

An estimated 600,000 American women suffer from PPD annually, making it one of the most frequent complications of pregnancy.

Impaired mother-infant bonding is a hallmark of PPD.

Depressed mothers may have difficulties developing maternal feelings and providing sensitive care.

In turn, impaired bonding may worsen mother's depression.

Who Took Part

56 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: At risk of postpartum depression (PPD).

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: failure to participate in regular prenatal check-ups; current diagnosis diagnostic and statistical manual of mental disorders (dsm-5) mental disorder pertaining to psychosis or substance abuse; obstetric complication (e.g., preeclampsia, excessive hemorrhaging).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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

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

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

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

It started in 2016-01 with completion listed for 2023-05.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Treatment Effect on Mother-infant Bonding (time frame: 5 days and 2 months postpartum (on average)).

It also tracked 3 secondary outcomes, for example Treatment Effect on Maternal Depression Symptoms and Treatment Effect on Maternal Anxiety Symptoms.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 56 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.