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

NCT03615794 | Completed

• 1 other identifier: IRB00027369
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Bipolar Disorder; Major Depressive Disorder; Postpartum Depression; Postpartum Psychosis

Outcome Measures

Primary Outcomes (1)

• Major depressive episode

  Development of a major depressive episode within the first 4 weeks postpartum

  4 weeks postpartum

Secondary Outcomes (2)

• Postpartum depression as assessed by Whole blood analysis

  Pregnancy and up to 6 months postpartum

• Postpartum depression risk as assessed by serum analysis

  Pregnancy and up to 6 months postpartum

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Virginia: collaborator

Study Sites (2)

550 North Broadway

Baltimore, Maryland, 21205, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

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Biospecimen

Retention: SAMPLES WITH DNA

Participants will undergo a blood draw at every in-person visit. Whole blood for genetic/epigenetic studies, serum for hormonal and immunological makers, and blood for a Complete Blood Count (CBC) will be collected.

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major; Depression, Postpartum

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jennifer Payne, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Richard Lee

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: October 1, 2017
• Primary Completion: January 31, 2024
• Study Completion: May 6, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)