Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001231
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
1999-11-03
Brief Title:
Perimenopause-Related Mood and Behavioral Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Evaluation of Women With Perimenopause-Related Mood and Behavioral Disorders
Status:
COMPLETED
Status Verified Date:
2024-06-05
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:
The purpose of this study is to investigate mood and behavior changes in the time period surrounding and including menopause This is an observational study volunteers who participate will not receive any new or experimental therapies
Controversy exists regarding the relationship between estrogen and progesterone gonadal steroid changes and midlife-onset depression This study will examine the role of gonadal steroids in perimenopausal mood and behavioral disorders
Perimenopausal women with depression symptoms and a control group of healthy perimenopausal volunteers will be compared to identify correlates of the occurrence of depression Participants with depressive symptoms may also participate in companion studies that will test the antidepressant efficacy of phytoestrogens and selective estrogen receptor modulators SERMS
A group of younger pre-perimenopausal women with normal menstrual cycle functioning will be followed through menopause in an effort to confirm the association of depression onset with changes in reproductive endocrine functioning
Controversy exists regarding the relationship between estrogen and progesterone gonadal steroid changes and midlife-onset depression This study will examine the role of gonadal steroids in perimenopausal mood and behavioral disorders
Perimenopausal women with depression symptoms and a control group of healthy perimenopausal volunteers will be compared to identify correlates of the occurrence of depression Participants with depressive symptoms may also participate in companion studies that will test the antidepressant efficacy of phytoestrogens and selective estrogen receptor modulators SERMS
A group of younger pre-perimenopausal women with normal menstrual cycle functioning will be followed through menopause in an effort to confirm the association of depression onset with changes in reproductive endocrine functioning
Detailed Description:
Controversy exists regarding the relevance of changes in gonadal steroids for midlife 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 depressions occurring during the perimenopause and for the collection of natural history data Women in this protocol will undergo an evaluation which may include a psychiatric 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 perimenopausal depression protocols eg DNA psychophysiology tests treatment studies etc for the purposes of better understanding the diagnosis pathophysiology and treatment response of women with depression during the perimenopauseUpon conclusion of the screening process participants will either be offered entry into 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 premenopausal women who are followed longitudinally through the menopause transition 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?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 88-M-0131 | None | None | None |