Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227942
Status:
COMPLETED
Last Update Posted:
2014-05-26
First Post:
2005-09-26
Brief Title:
Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia
Sponsor:
Hadine Joffe MD
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Understanding the Role That Hot Flashes and Sleep Disruption Play in the Effect of Estrogen Replacement Therapy on Mood in Perimenopausal and Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2014-05
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:
This study will evaluate the effectiveness of estrogen replacement therapy in treating depression in menopausal women with hot flashes and insomnia
Detailed Description:
Estrogen is a hormone that plays an important part in the development of the female reproductive system During menopause estrogen levels drop significantly The drop in estrogen may cause physiologic and psychological changes in women common symptoms include hot flashes sweating insomnia and irritability In addition approximately 10 of menopausal women experience depression Estrogen replacement therapy ERT is often prescribed to alleviate these symptoms It is not known however exactly how ERT treats depression It may indirectly decrease depression by alleviating insomnia associated with hot flashes or it may directly improve mood and decrease depression by altering chemicals in the brain The purpose of this study is to gain insight into how ERT treats depression and to develop strategies to reduce depression in menopausal women In turn these findings may help categorize populations of women whose depression should be treated with ERT versus nonhormonal therapies
In this 9-week study participants will be randomly assigned to receive ERT a sleeping pill or placebo Study visits will occur at baseline and Weeks 2 4 6 and 9 at each study visit blood pressure will be monitored and standardized psychological tests and questionnaires will be used to assess the participants level of depression and reported quality of life outcomes Blood will be drawn at baseline and Week 9 to measure estrogen and follicle stimulating hormone levels
In this 9-week study participants will be randomly assigned to receive ERT a sleeping pill or placebo Study visits will occur at baseline and Weeks 2 4 6 and 9 at each study visit blood pressure will be monitored and standardized psychological tests and questionnaires will be used to assess the participants level of depression and reported quality of life outcomes Blood will be drawn at baseline and Week 9 to measure estrogen and follicle stimulating hormone levels
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 |
|---|---|---|---|
| DATR AK-TNAI1 | US NIH GrantContract | None | httpsreporternihgovquickSearchK23MH066978 |
| K23MH066978 | NIH | None | None |