Ignite Creation Date:
2024-05-05 @ 11:24 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01328613
Status:
TERMINATED
Last Update Posted:
2019-12-04
First Post:
2011-04-01
Brief Title:
A Prospective Study of Postpartum Depression in Women With Major Depression
Sponsor:
National Institute on Aging NIA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Prospective Study of Postpartum Depression in Women With Major Depression
Status:
TERMINATED
Status Verified Date:
2014-09-29
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
- 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 08-AG-N320 | None | None | None |