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The Effects of Estrogen Withdrawal on Mood Symptoms in Women

NCT00060736 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-12-16

No results posted yet for this study

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.

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Conditions

  • Perimenopausal Depression
  • Post Menopausal
  • Healthy
  • Depression

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Peter J Schmidt, M.D. · National Institute of Mental Health (NIMH)

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-05
Completion
2016-04-27

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00060736 on ClinicalTrials.gov