Clinical trial NCT03615794: A Study of Pregnant and Postpartum Women With and Without Mood Disorders
Official title: A Prospective Study of Pregnant and Postpartum Women With and Without Mood Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bipolar Disorder
Major Depressive Disorder
Postpartum Depression
Postpartum Psychosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Virginia
First posted: 2018-08-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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

Eligibility 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

Primary outcomes:
measure: Major depressive episode
timeFrame: 4 weeks postpartum
Secondary outcomes:
measure: Postpartum depression as assessed by Whole blood analysis
timeFrame: Pregnancy and up to 6 months postpartum
measure: Postpartum depression risk as assessed by serum analysis
timeFrame: Pregnancy and up to 6 months postpartum
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: 550 North Broadway
state: Maryland
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Jennifer Payne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Richard Lee
role: PRINCIPAL_INVESTIGATOR
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