NCT00060736

The Effects of Estrogen Withdrawal on Mood Symptoms in Women

Completed Last updated 16 December 2019

What this trial tests

trial in Perimenopausal Depression in 60 participants. Completed in 27 April 2016.

Timeline

5 May 2003

27 April 2016

Quick facts

Lead sponsor	National Institute of Mental Health (NIMH)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	60
Start date	5 May 2003
Estimated completion	27 April 2016
Sites	1 location across United States

Conditions studied

• Perimenopausal Depression — all drugs for Perimenopausal Depression →
• Post Menopausal — all drugs for Post Menopausal →
• Healthy — all drugs for Healthy →
• Depression — all drugs for Depression →

Sponsor

National Institute of Mental Health (NIMH)

Who can join

Adults 45 to 65, female only, with Perimenopausal Depression or Post Menopausal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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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Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of Estradiol Withdrawal on Mood in Women With Past Perimenopausal Depression: A Randomized Clinical Trial.
   Schmidt PJ, Ben Dor R, Martinez PE, Guerrieri GM, et al · · 2015 · cited 161× · PMID 26018333 · DOI 10.1001/jamapsychiatry.2015.0111
2. In vitro model of perimenopausal depression implicates steroid metabolic and proinflammatory genes.
   Rudzinskas S, Hoffman JF, Martinez P, Rubinow DR, et al · · 2021 · cited 11× · PMID 32788687 · DOI 10.1038/s41380-020-00860-x