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Estrogen and Perimenopausal Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00229450
Recruitment Status : Unknown
Verified June 2008 by University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : September 29, 2005
Last Update Posted : June 4, 2008
National Alliance for Research on Schizophrenia and Depression
Information provided by:
University of California, Los Angeles

Brief Summary:
During perimenopause (the time just prior to menopause), women often notice many biological, psychological, and social changes. In particular, some women experience depressive symptoms during perimenopause that are severe enough to warrant antidepressant medication. Whether or not women with perimenopausal depression respond to antidepressant medication may depend on the level of estrogen in their blood. We would like to investigate whether estrogen will help the women who only partially respond to antidepressant medications. We also want to examine how different doses of estrogen may affect individuals differently.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Menopause Drug: estrogen Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Dose Response Effects of Estrogen Augmentation in Mood & Memory in Perimenopausal Depression
Study Start Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
Drug Information available for: Estrogens

Primary Outcome Measures :
  1. Mood

Secondary Outcome Measures :
  1. Memory

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical Diagnosis of Unipolar Major Depression, currently taking antidepressants
  • HAM-D between 10 and 17

Exclusion Criteria:

  • History of Psychosis, breast cancer, smoking, dementia, clotting disorders
  • Current substance abuse

Information from the National Library of Medicine

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 identifier (NCT number): NCT00229450

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Contact: Melinda L. Morgan, Ph.D. 310-825-5028

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United States, California
UCLA Neuropsychiatric Institute & Hospital Recruiting
Los Angeles, California, United States, 90024
Contact: Jodie B. Cohen, B.S.    310-825-0528   
Sub-Investigator: Ian A. Cook, M.D.         
Sub-Investigator: Andrew F. Leuchter, M.D.         
Sponsors and Collaborators
University of California, Los Angeles
National Alliance for Research on Schizophrenia and Depression
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Principal Investigator: Melinda L. Morgan, Ph.D. University of California, Los Angeles

Layout table for additonal information Identifier: NCT00229450     History of Changes
Other Study ID Numbers: NARSAD06806-001
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008
Keywords provided by University of California, Los Angeles:
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs