Estrogen and Perimenopausal Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00229450
First received: September 28, 2005
Last updated: June 2, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Depressive Disorder, Major
Menopause
Drug: estrogen
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Dose Response Effects of Estrogen Augmentation in Mood & Memory in Perimenopausal Depression

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Mood

Secondary Outcome Measures:
  • Memory

Estimated Enrollment: 20
Study Start Date: October 2004
  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229450

Contacts
Contact: Melinda L. Morgan, Ph.D. 310-825-5028 melinda@ucla.edu

Locations
United States, California
UCLA Neuropsychiatric Institute & Hospital Recruiting
Los Angeles, California, United States, 90024
Contact: Jodie B. Cohen, B.S.    310-825-0528    jodie@mentalhealth.ucla.edu   
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
Investigators
Principal Investigator: Melinda L. Morgan, Ph.D. University of California, Los Angeles
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00229450     History of Changes
Other Study ID Numbers: NARSAD06806-001, 06806-001, 04-05-088
Study First Received: September 28, 2005
Last Updated: June 2, 2008
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
depression
menopause
perimenopause
mood
memory
perimenopausal
antidepressant
estrogen

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014