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

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03615794
Collaborator
University of Virginia (Other)
400
2
84
200
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Study of Pregnant and Postpartum Women With and Without Mood Disorders
    Actual Study Start Date :
    Oct 1, 2017
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Oct 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Major depressive episode [4 weeks postpartum]

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

    Secondary Outcome Measures

    1. Postpartum depression as assessed by Whole blood analysis [Pregnancy and up to 6 months postpartum]

      Analyze whole blood to identify genetic and epigenetic risk factors for postpartum depression.

    2. Postpartum depression risk as assessed by serum analysis [Pregnancy and up to 6 months postpartum]

      Analyze serum samples to identify hormonal and immunological risk factors for postpartum depression.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 550 North Broadway Baltimore Maryland United States 21205
    2 University of Virginia Charlottesville Virginia United States 22908

    Sponsors and Collaborators

    • Johns Hopkins University
    • University of Virginia

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT03615794
    Other Study ID Numbers:
    • IRB00027369
    First Posted:
    Aug 6, 2018
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 14, 2022