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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03615794
• Other study ID #: IRB00027369
• Status: Active, not recruiting
• Start date: October 1, 2017
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression, Postpartum
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Mood Disorders
• Postpartum Depression
• Postpartum Psychosis

Locations

Country	Name	City	State
United States	550 North Broadway	Baltimore	Maryland
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (51)

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major depressive episode	Development of a major depressive episode within the first 4 weeks postpartum	4 weeks postpartum
Secondary	Postpartum depression as assessed by Whole blood analysis	Analyze whole blood to identify genetic and epigenetic risk factors for postpartum depression.	Pregnancy and up to 6 months postpartum
Secondary	Postpartum depression risk as assessed by serum analysis	Analyze serum samples to identify hormonal and immunological risk factors for postpartum depression.	Pregnancy and up to 6 months postpartum