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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.
 
ClinicalTrials.gov Identifier: NCT00229450
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : February 25, 2020
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
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. 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Response Effects of Estrogen Augmentation in Mood & Memory in Perimenopausal Depression
Study Start Date : April 2002
Actual Primary Completion Date : August 2003
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
Drug Information available for: Estrogens

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00229450


Locations
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United States, California
UCLA Neuropsychiatric Institute & Hospital
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
National Alliance for Research on Schizophrenia and Depression
Investigators
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Principal Investigator: Melinda L. Morgan, Ph.D. University of California, Los Angeles

Publications:
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Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00229450    
Other Study ID Numbers: NARSAD06806-001
06806-001
04-05-088
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Keywords provided by University of California, Los Angeles:
depression
menopause
perimenopause
mood
memory
perimenopausal
antidepressant
estrogen
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs