A Study of Pregnant and Postpartum Women With and Without Mood Disorders
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|ClinicalTrials.gov Identifier: NCT03615794|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : November 12, 2020
|Condition or disease|
|Bipolar Disorder Major Depressive Disorder Postpartum Depression Postpartum Psychosis|
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|
|Estimated Enrollment :||400 participants|
|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|
Pregnant women with Mood Disorders
Pregnant women with a history or current diagnosis of Major Depressive Disorder or Bipolar Disorder
Pregnant women without a history or current diagnosis of a mood disorder.
- Major depressive episode [ Time Frame: 4 weeks postpartum ]Development of a major depressive episode within the first 4 weeks postpartum
- 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.
- 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
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
|Contact: Jennifer Payne, MDfirstname.lastname@example.org|
|United States, Maryland|
|550 North Broadway||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Samantha Meilman, MSW 410-502-2586 email@example.com|
|Principal Investigator:||Jennifer Payne, MD||Johns Hopkins University|