A Prospective Study of Postpartum Depression in Women With Major Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT01328613
First received: April 1, 2011
Last updated: March 14, 2014
Last verified: July 2012
  Purpose

Background:

- Postpartum depression (PPD) is a serious syndrome that resembles a major depressive episode and occurs in 10% to 20% of all mothers in the year following delivery. Women with histories of major depressive disorder (MDD) are at an increased risk for PPD and recurrent PPD with subsequent pregnancies. One possible genetic vulnerability to depression and PPD in particular is the BDNF gene. BDNF is a protein that affects the growth and development of brain cells, including those that help to regulate mood. BDNF levels have been shown to be significantly lower in individuals with depression, including women. Researchers are interested in studying BDNF levels and hormones such as estrogen in pregnant women who have MDD and are at risk for developing PPD.

Objectives:

- To study connections between the BDNF protein and hormonal levels in pregnant women who are at risk for developing postpartum depression.

Eligibility:

- Women who are currently pregnant and have a history of major depressive disorder, and either are taking a selective serotonin reuptake inhibitor (SSRI) or are not taking an antidepressant.

Design:

  • This study involves six visits over the course of 12 months, during the first, second, and third trimesters (if possible) as well as 1 week, 1 month, and 3 months postpartum. Women will be allowed to participate at any point during pregnancy, but researchers are most interested in recruiting women who are in the first trimester.
  • Participants will be screened with a physical examination and medical history, blood samples, and questionnaires about their history of depressive episodes.
  • At each visit, participants will complete a number of questionnaires on depression symptoms, such as sleep disturbance and stress levels. Participants will also provide blood samples for hormone and other testing.
  • Participants who become depressed during the study will be referred to a treating psychiatrist or other professional for appropriate care and treatment.

Condition
Postpartum Depression

Study Type: Observational
Official Title: A Prospective Study of Postpartum Depression in Women With Major Depression

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 120
Study Start Date: November 2007
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. The etiology of PPD involves psychological factors, environmental factors such as stress and sleep deprivation, biological factors including hormonal changes, and social factors. Women with histories of major depression (MDD) are at an increased risk for PPD and recurrent PPD with subsequent pregnancies. No consistent hormonal abnormalities have been found in women with PPD and, instead, they may be sensitive to the normal changes in hormone levels during the postpartum time. One possible genetic vulnerability to depression, and in particular PPD, is the brain-derived neurotrophic factor (BDNF) gene. BDNF is an important member of the neurotrophin family and is known to affect neuronal outgrowth, differentiation, synaptic connectivity and neuronal repair for a broad range of neuronal cell types including serotonergic neurons. In humans, serum BDNF levels have been shown to be significantly lower in patients with depression, including women . Interestingly, estrogen has been shown to upregulate the expression of the BDNF gene in animals, suggesting that BDNF could be a critical link for women who have hormonally related depressive symptoms. In addition, serotonin-selective reuptake inhibitors (SSRI) used to treat depression are known to upregulate the expression of BDNF in the brain. Interestingly, links between depression, perturbed energy metabolism and BDNF signaling have recently been elucidated. In the present study, NIA investigators will measure levels of BDNF and reproductive and energy-regulating hormones in serum samples from subjects enrolled in Dr. Jennifer Payne s study of PPD.

All subjects in this study will be enrolled, evaluated and serum samples collected by Dr. Payne and her staff at Johns Hopkins University School of Medicine under Dr. Payne s already Johns Hopkins approved IRB protocol NA_0008149.

NIA Role:

Coded serum samples will then be sent to Dr. Mattson at the NIA facility. Data obtained in the analysis of serum samples will be sent to Dr. Payne and maintained in her database, and analyzed to elucidate relations between levels of serum markers and clinical and genetic data acquired by Dr. Payne.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Women who are currently pregnant and who have a history of MDD.

In order to minimize heterogeneity in the sample, all women must be currently taking a serotonin reuptake inhibitor (SSRI) antidepressant medication or not taking antidepressants.

We will attempt to recruit approximately 50% in each category (SSRI versus no medications). If a woman becomes depressed during the study she will be referred to her treating psychiatrist or given appropriate clinical care. We will continue to follow women for the specified time course even if she placed on an (any) antidepressant medication during the course of the study.

EXCLUSION CRITERIA:

Diagnosis of bipolar disorder

Current active suicidal ideation or medical instability

Active substance abuse or dependence during the last 90 days.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328613

Locations
United States, Maryland
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Investigators
Principal Investigator: Mark P Mattson, Ph.D. National Institute on Aging (NIA)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT01328613     History of Changes
Other Study ID Numbers: 999908320, 08-AG-N320
Study First Received: April 1, 2011
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
BDNF
Homeosis
Women
Childbirth
Major Depressive Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on September 18, 2014