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OpenTrials
Completed

NCT Number: NCT00229450

Estrogen and Perimenopausal Depression

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. This study will investigate whether estrogen will help women who only partially respond to antidepressant medications, as well as examine how different doses of estrogen may affect individuals differently.

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Key information

Conditions

Depressive Disorder, Major Behavior Behavioral Symptoms Depression Depressive Disorder Menopause Mental Disorders Mood Disorders

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UCLA Neuropsychiatric Institute & Hospital

Los Angeles, California, 90024, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estrogen

Drug

0.625 mg/day of conjugated Estrogen

Primary outcomes

  1. Mood

    Time frame: 6 weeks

    17-item Hamilton Depression (HAM-D17) scores range from 0 to 50, and lower scores are better outcomes.

Secondary outcomes

  1. Memory

    Time frame: 6 weeks

    The Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Consistent Long-Term Retrieval score is the number of words that the subject recalls without receiving prompts and indicates how well the subject consolidates the new information during the learning phase (encoding). Scores indicate the sum of consistent long-term word retrieval across the 12 trials and range from 0 to 144, with higher scores indicating better learning.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression

Registry information

Official study title

Dose Response Effects of Estrogen Augmentation in Mood & Memory in Perimenopausal Depression

Important dates

Study start
2002
Primary completion
2003
Study completion
2004
First posted
Sep 29, 2005
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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