Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056901
Status:
TERMINATED
Last Update Posted:
2018-02-14
First Post:
2003-03-26
Brief Title:
Screening Evaluation for Women With Postpartum Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Screening Protocol to Evaluate Women With Postpartum-Related Mood and Behavioral Disorders
Status:
TERMINATED
Status Verified Date:
2017-12-24
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:
This study evaluates the relationship between mood changes and hormones in women with postpartum depression PPD
This is an observational study volunteers who participate will not receive any new or experimental therapies
PPD is similar to major depression but develops around the time a woman gives birth Women with PPD often suffer serious physical and emotional impairments Controversy exists regarding the role of hormone changes in postpartum depression This study will examine the role of hormone changes in three groups of women those who recently gave birth and have mild to moderately severe PDD Group 1 women who recently gave birth and do not have PDD Group 2 and those who are currently pregnant and experienced an episode of PDD with a previous birth Group 3
Participants will be screened with a medical history physical examination and blood and urine tests Upon study entry they will be interviewed about their moods behaviors and medical status during and immediately following their last pregnancy Some women will be asked to participate in interviews psychological tests and blood tests They will also complete self-rating scales and may be asked to collect samples of their urine Women in Group 3 will complete self-rating scales for 6 months postpartum Participants will participate in genetic studies that involve completing a questionnaire and providing a blood sample If the participant allows sisters and parents may be asked to provide a blood sample and undergo a psychiatric interview
Participants who meet the criteria for minor depression or major depression that is no greater than moderate severity will be asked to participate in a companion study that will evaluate the effectiveness of estradiol in reducing depression symptoms
This is an observational study volunteers who participate will not receive any new or experimental therapies
PPD is similar to major depression but develops around the time a woman gives birth Women with PPD often suffer serious physical and emotional impairments Controversy exists regarding the role of hormone changes in postpartum depression This study will examine the role of hormone changes in three groups of women those who recently gave birth and have mild to moderately severe PDD Group 1 women who recently gave birth and do not have PDD Group 2 and those who are currently pregnant and experienced an episode of PDD with a previous birth Group 3
Participants will be screened with a medical history physical examination and blood and urine tests Upon study entry they will be interviewed about their moods behaviors and medical status during and immediately following their last pregnancy Some women will be asked to participate in interviews psychological tests and blood tests They will also complete self-rating scales and may be asked to collect samples of their urine Women in Group 3 will complete self-rating scales for 6 months postpartum Participants will participate in genetic studies that involve completing a questionnaire and providing a blood sample If the participant allows sisters and parents may be asked to provide a blood sample and undergo a psychiatric interview
Participants who meet the criteria for minor depression or major depression that is no greater than moderate severity will be asked to participate in a companion study that will evaluate the effectiveness of estradiol in reducing depression symptoms
Detailed Description:
Controversy exists regarding the relevance of changes in gonadal steroids for postpartum-onset depressions The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols that examine the role of gonadal steroids in postpartum-onset depressions PPD and for the collection of natural history data Women in this protocol will undergo an evaluation which may include a psychiatric interview a diagnostic interview rating scales a medical history a physical exam blood and urine laboratory evaluation and a request for medical records The data collected may also be linked with data from other PPD protocols eg DNA psychophysiology tests treatment studies etc for the purposes of better understanding the diagnosis pathophysiology and treatment response of women with PPD Upon conclusion of the screening process subjects will either be offered participation in a research protocol and will sign the appropriate informed consent or will be considered not appropriate for participation in research and will be referred back into the community The second purpose of this protocol is to permit the identification of pregnant women who are at risk for developing postpartum depression PPD and who are followed longitudinally through the postpartum in an effort to confirm the association of depression onset with change in reproductive endocrine function This protocol then serves as a screening and evaluation protocol to recruit subjects who are characterized with standard measures in this protocol and then offered participation in related studies
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 |
|---|---|---|---|
| 03-M-0138 | None | None | None |