The Effects of Estrogen Withdrawal on Mood Symptoms in Women
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|ClinicalTrials.gov Identifier: NCT00060736|
Recruitment Status : Completed
First Posted : May 12, 2003
Last Update Posted : March 12, 2018
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.
|Condition or disease|
|Perimenopausal Depression Post Menopausal Healthy Depression|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||The Effects of Acute Withdrawal of Estradiol on Mood Symptoms in Women With Perimenopausal Depression|
|Study Start Date :||May 5, 2003|
|Estimated Study Completion Date :||April 27, 2016|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060736
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Peter J Schmidt, M.D.||National Institute of Mental Health (NIMH)|