Estrogen and Perimenopausal Depression

Study Overview
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Brief Summary
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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.

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

Conditions
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Depressive Disorder, Major, Menopause

Intervention / Treatment
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* Drug: Estrogen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>0.625 mg/day of conjugated estrogen | Drug: Estrogen<br>* 0.625 mg/day of conjugated Estrogen<br>|
| Placebo Comparator: Placebo<br>Daily placebo for conjugated estrogen | Drug: Estrogen<br>* 0.625 mg/day of conjugated Estrogen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, menopause, perimenopause, mood, memory, perimenopausal, antidepressant, estrogen