Postpartum DepressionNCT01328613
A Prospective Study of Postpartum Depression in Women With Major Depression
An observational study of Postpartum Depression, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2007to 29 Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of bipolar disorder
- Current active suicidal ideation or medical instability
- Active substance abuse or dependence during the last 90 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Postpartum Depression
- Keywords
- BDNF, Homeosis, Women, Childbirth, Major Depressive Disorder
- Medical subject headings
- Depression, Postpartum, Depressive Disorder, Major
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study start9 Nov 2007
- Study completion29 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark P Mattson, Ph.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328613
- Sponsor's protocol ID
- 999908320
- Other IDs
- 08-AG-N320
- Status last verified
- 29 Sep 2014
- First submitted
- 1 Apr 2011
- Last updated
- 4 Dec 2019
- Results posted
- No
Publications
Campbell SB, Cohn JF. Prevalence and correlates of postpartum depression in first-time mothers. J Abnorm Psychol. 1991 Nov;100(4):594-9. doi: 10.1037//0021-843x.100.4.594.
PubMed 1757673Hunt N, Silverstone T. Does puerperal illness distinguish a subgroup of bipolar patients? J Affect Disord. 1995 May 17;34(2):101-7. doi: 10.1016/0165-0327(95)00006-9.
PubMed 7665801Kumar R, Robson KM. A prospective study of emotional disorders in childbearing women. Br J Psychiatry. 1984 Jan;144:35-47. doi: 10.1192/bjp.144.1.35.
PubMed 6692075
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Postpartum Depression in Women With Major Depression
- ClinicalTrials.gov ID
- NCT01328613
- Acronym / sponsor ID
- 999908320
- Conditions
- Postpartum Depression
- Keywords
- BDNF, Homeosis, Women, Childbirth, Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 85 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 9 Nov 2007
- Study completion
- 29 Sep 2014
- First posted
- 4 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Diagnosis of bipolar disorder
- Current active suicidal ideation or medical instability
- Active substance abuse or dependence during the last 90 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Background: PubMed 1757673Campbell SB, Cohn JF. Prevalence and correlates of postpartum depression in first-time mothers. J Abnorm Psychol. 1991 Nov;100(4):594-9. doi: 10.1037//0021-843x.100.4.594.
- Background: PubMed 7665801Hunt N, Silverstone T. Does puerperal illness distinguish a subgroup of bipolar patients? J Affect Disord. 1995 May 17;34(2):101-7. doi: 10.1016/0165-0327(95)00006-9.
- Background: PubMed 6692075Kumar R, Robson KM. A prospective study of emotional disorders in childbearing women. Br J Psychiatry. 1984 Jan;144:35-47. doi: 10.1192/bjp.144.1.35.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark P Mattson, Ph.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01328613, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.