The Effects of Estrogen Withdrawal on Mood Symptoms in Women
Completed
Conditions studied: Perimenopausal Depression, Post Menopausal, Healthy, Depression
In brief
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. ...
Key facts
- Study ID
- NCT00060736
- Run by
- National Institute of Mental Health (NIMH)
- People needed
- 60
- Starts
- 2003-05-05
- Expected to finish
- 2016-04-27
- Last updated by the study team
- 2019-12-16
Who can join
Age: 45 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- past history of severe major depression with suicidal ideation
- current treatment with antidepressant medications
- history of ischemic cardiac disease, pulmonary embolism, or thrombophlebitis
- renal disease
- hepatic dysfunction
- women with a history of carcinoma of the breast
- women with a history of uterine cancer, ill-defined pelvic lesions, particularly undiagnosed ovarian enlargement, undiagnosed vaginal bleeding
- pregnant women
- cerebrovascular disease (stroke)
- recurrent migraine headaches
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.