Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03615794
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Bipolar Disorder Major Depressive Disorder Postpartum Depression Postpartum Psychosis

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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 : October 1, 2017
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Major depressive episode [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Pregnancy and up to 6 months postpartum ]
    Analyze serum samples to identify hormonal and immunological risk factors for postpartum depression.


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.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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).
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615794


Contacts
Layout table for location contacts
Contact: Jennifer Payne, MD 410-502-0050 jpayne5@jhmi.edu

Locations
Layout table for location information
United States, Maryland
550 North Broadway Recruiting
Baltimore, Maryland, United States, 21205
Contact: Samantha Meilman, MSW    410-502-2586    smeilma1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Jennifer Payne, MD Johns Hopkins University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
Bernstein, D. and L. Fink, Manual for the childhood trauma questionnaire. The Psychological Corporation, New York, 1998
20) Guy W. Clinical global impression. ECDEU Assessment Manual for Psychopharmacology, Revised 1976, National Institute of Mental Health, Rockville, MD.
35) O'Hara MW, Varner, MW. (1986). Assessing stressful life events associated with childbearing: The Peripartum Events Scale. J of Repro and Inf Psych 4: 85-98.

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03615794    
Other Study ID Numbers: IRB00027369
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression, Postpartum
Disease
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Mood Disorders
 Pathologic Processes
Mental Disorders
Bipolar and Related Disorders
Puerperal Disorders
Pregnancy Complications