Estrogen and Perimenopausal Depression

February 21, 2020 updated by: University of California, Los Angeles

Dose Response Effects of Estrogen Augmentation in Mood & Memory in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA Neuropsychiatric Institute & Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
0.625 mg/day of conjugated estrogen
Drug: Estrogen
0.625 mg/day of conjugated Estrogen
Placebo Comparator: Placebo
Daily placebo for conjugated estrogen
Drug: Estrogen
0.625 mg/day of conjugated Estrogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood
Time Frame: 6 weeks
17-item Hamilton Depression (HAM-D17) scores range from 0 to 50, and lower scores are better outcomes.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Alliance for Research on Schizophrenia and Depression

Investigators

  • Principal Investigator: Melinda L. Morgan, Ph.D., University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

September 28, 2005

First Submitted That Met QC Criteria

September 28, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NARSAD06806-001
  • 06806-001
  • 04-05-088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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