Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060736
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2003-05-09
Brief Title:
The Effects of Estrogen Withdrawal on Mood Symptoms in Women
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effects of Acute Withdrawal of Estradiol on Mood Symptoms in Women With Perimenopausal Depression
Status:
COMPLETED
Status Verified Date:
2016-04-27
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 effects on mood when stopping estrogen replacement therapy
The purpose of this study is to investigate the effects of estrogen levels on perimenopausal depression This study will examine short-term withdrawal of estrogen in women whose mood had improved with estrogen therapy
Perimenopause-related mood disorders cause significant distress in a large number of women Evidence suggests that estradiol may have beneficial effects in women with perimenopausal depression However the effect of declining estradiol secretion during perimenopause has not been fully examined
Peri- and post-menopausal women who experience a remission of perimenopause-related depression symptoms while on estrogen therapy and a control group of healthy volunteers on hormone replacement therapy HRT will be switched from their current form of HRT to estradiol for a 3-week period volunteers will also complete symptom ratings to confirm the absence of mood symptoms Participants will then be randomly assigned to either continue estradiol or take a placebo an inactive pill for an additional 3 weeks Mood ratings will be used to determine response to estradiol withdrawal
The purpose of this study is to investigate the effects of estrogen levels on perimenopausal depression This study will examine short-term withdrawal of estrogen in women whose mood had improved with estrogen therapy
Perimenopause-related mood disorders cause significant distress in a large number of women Evidence suggests that estradiol may have beneficial effects in women with perimenopausal depression However the effect of declining estradiol secretion during perimenopause has not been fully examined
Peri- and post-menopausal women who experience a remission of perimenopause-related depression symptoms while on estrogen therapy and a control group of healthy volunteers on hormone replacement therapy HRT will be switched from their current form of HRT to estradiol for a 3-week period volunteers will also complete symptom ratings to confirm the absence of mood symptoms Participants will then be randomly assigned to either continue estradiol or take a placebo an inactive pill for an additional 3 weeks Mood ratings will be used to determine response to estradiol withdrawal
Detailed Description:
Perimenopause-related mood disorders cause significant distress to a large number of women Recent studies have reported the therapeutic benefits of estradiol in women with these mood disorders however a relevant pathophysiologic role of declining estradiol secretion during the perimenopause has not been demonstrated In this protocol we wish to investigate the effects of acute withdrawal of estradiol on mood under placebo controlled conditions Thus mood and behavior symptoms may be precipitated by the experimental conditions of this protocol This protocol will address the following hypothesis women with a past history of perimenopause-related depression but not women without such a history will experience a recurrence of mood and behavioral symptoms during acute estradiol withdrawal but not during continued estradiol administration The nature of the relationship between the declining secretion of estradiol and mood in perimenopausal depressed women will be examined as follows Peri- and postmenopausal women reporting the onset of depression during the perimenopause and who report remission of depressive symptoms on estrogen therapy ET will be withdrawn from ET under blinded and placebo-controlled conditions We will recruit as a comparison group asymptomatic women on hormone replacement and without a history of perimenopause-related depression During a three week baseline phase all women will be switched from their current form of hormone replacement therapy to estradiol and will complete symptom ratings to confirm the absence of mood symptoms prior to entry into the study After the screening all women will be randomized to receive either estradiol or placebo for an additional three weeks Comparison of mood ratings during these contrasting treatment conditions will allow us to examine the specific role of estrogen withdrawal in depression that is responsive to ET
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-0175 | None | None | None |