Neurophysiology of Postpartum Depression in an Experimental Model of Pregnancy and Parturition

What Was Tested

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

It had two arms (groups): one (experimental) and Women without any psychiatric history (Control) (experimental).

The registry classes the interventions as drug.

More on the Plan

However, little is known about the neurobiological mechanisms underlying depressive disorders in women.

Moreover, identifying a neurophysiologic biomarker for hormone-related affective dysfunction provides a clear pathway for examining mechanisms of susceptibility to affective dysfunction across disorders.

An additional exploratory aim is to identify a neural biomarker, characterized by corticolimbic and reward circuit dysfunction, that can be used to predict the onset of PPD.

This endocrine manipulation paradigm will be used to examine the neurocircuitry underlying the regulation of affect and reward processing under baseline and hormone withdrawal-precipitated conditions among women who are expected to experience hormone-related affective dysregulation (n=15) and controls (n=15).

Who Took Part

Enrollment: 36 actual participants took part.

It was open to women only aged from 22 years up to 50 years.

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

Examples of who could join: Has been well for a minimum of one year;. A regular menstrual cycle for at least three months;. Medication free (not including birth control pills; participants may opt to temporarily discontinue birth control pills to participate);. No history of puerperal suicide attempts or psychotic episodes requiring hospitalization.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: current axis i psychiatric diagnosis; undiagnosed enlargement of the ovaries;; liver disease;.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-08 with completion listed for 2016-10-13.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Blood-oxygen-level-dependent (BOLD) Response During Functional Magnetic Resonance Imaging (fMRI) z Statistic (time frame: baseline and hormone withdrawal).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Leuprolide in 36 people.

Its size is small, so on its own it can only give an early look.

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

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