A Study of Pregnant and Postpartum Women With and Without Mood Disorders

December 22, 2025 updated by: Johns Hopkins University

A Prospective Study of Pregnant and Postpartum Women With and Without Mood Disorders

This study is looking at genetic, biological, and environmental causes and how all three may work together to cause postpartum mood episodes. Participants will have psychiatric histories taken and will be monitored throughout pregnancy and during the postpartum period for the development of depressive or other mood episodes. Biological measures, including hormone levels, immunological measures, and growth factors will be collected. Environmental factors such as sleep deprivation and stress will also be measured. These factors will be considered in the setting of genetic and epigenetic data with the hope that investigators will ultimately be able to predict the onset of postpartum mood episodes in this vulnerable population.

Study Overview

Status

Completed

Conditions

Detailed Description

Postpartum Depression (PPD) is a serious syndrome which resembles a major depressive episode and occurs in 10-20% of all mothers in the year following delivery. In addition, 20 - 30 % of women with Bipolar Disorder will experience postpartum psychosis (mania) and at least 20 % will experience a postpartum depression with some estimates as high as 65%. The postpartum time therefore represents a natural experiment that, in the setting of prospective monitoring, will allow the measurement of biological, genetic, and environmental factors that may impact the development of mood episodes.

Data was previously collected in "A Prospective Study of Postpartum Mood Episodes in Women with Affective disorders." Investigators followed 93 women with a history of a mood disorder (Major Depressive Disorder, Bipolar I, Bipolar II or Bipolar Not Otherwise Specified) through pregnancy and up to three months postpartum. This was a very ill sample and around 75% of the participants met Diagnostic and Statistical Manual (DSM)-IV criteria for a Major Depressive Episode either during pregnancy, postpartum or both. Of those that were well during the 3rd trimester (N=38), 40% became depressed within 4 weeks of delivery, despite the fact that 80% were taking psychiatric medications. Of those that developed Postpartum Depression, 53% had a family history of Postpartum Depression compared to 12% of those that did not develop Postpartum Depression, thus demonstrating a potential genetic basis for Postpartum Depression. Using this sample, investigators were able to identify epigenetic biomarkers that were predictive of Postpartum Depressive episodes.

Investigators now seek to replicate and extend investigators' previous findings by identifying and following a second sample of women with mood disorders through pregnancy and into the postpartum time period and, in addition, collect a sample of pregnant women who do not have a history of mood disorder as a control sample. These women will have psychiatric histories taken and will be monitored throughout pregnancy and during the postpartum period for the development of depressive or other mood episodes. In addition to clinical data, biological measures such as hormone levels, immunological measures and growth factors will be taken. Environmental factors such as sleep deprivation and stress will also be measured. These factors will be considered in the setting of genetic and epigenetic data with the hope that investigators will ultimately be able to predict the onset of postpartum mood episodes in this vulnerable population. An understanding of the biological basis of postpartum episodes will ultimately shed light on the vulnerability to Major Depressive Disorder and Bipolar Disorder in general

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Baltimore, Maryland, United States, 21205
    - 550 North Broadway
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with or without a history of a mood disorder (Major Depression, Bipolar I, Bipolar II, or Bipolar NOS).

Description

Inclusion Criteria:

Pregnant women with singleton pregnancies
With or without a history of a mood disorder (MDD, Bipolar I, Bipolar II or Bipolar NOS)

Exclusion Criteria:

Current active suicidal ideation
Medical or psychiatric instability
Active substance abuse or dependence during the last 90 days
Presence or development of significant pregnancy conditions that may have independent effects on outcomes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Pregnant women with Mood Disorders Pregnant women with a history or current diagnosis of Major Depressive Disorder or Bipolar Disorder
Healthy controls Pregnant women without a history or current diagnosis of a mood disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major depressive episode Time Frame: 4 weeks postpartum	Development of a major depressive episode within the first 4 weeks postpartum	4 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum depression as assessed by Whole blood analysis Time Frame: Pregnancy and up to 6 months postpartum	Analyze whole blood to identify genetic and epigenetic risk factors for postpartum depression.	Pregnancy and up to 6 months postpartum
Postpartum depression risk as assessed by serum analysis Time Frame: Pregnancy and up to 6 months postpartum	Analyze serum samples to identify hormonal and immunological risk factors for postpartum depression.	Pregnancy and up to 6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

University of Virginia

Investigators

Principal Investigator: Richard Lee, Johns Hopkins University
Principal Investigator: Jennifer Payne, MD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

May 6, 2024

Study Registration Dates

First Submitted

July 31, 2018

First Submitted That Met QC Criteria