Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of estrogen replacement therapy in treating depression in menopausal women with hot flashes and insomnia.

Detailed Description
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Estrogen is a hormone that plays an important part in the development of the female reproductive system. During menopause, estrogen levels drop significantly. The drop in estrogen may cause physiologic and psychological changes in women; common symptoms include hot flashes, sweating, insomnia, and irritability. In addition, approximately 10% of menopausal women experience depression. Estrogen replacement therapy (ERT) is often prescribed to alleviate these symptoms. It is not known, however, exactly how ERT treats depression. It may indirectly decrease depression by alleviating insomnia associated with hot flashes, or it may directly improve mood and decrease depression by altering chemicals in the brain. The purpose of this study is to gain insight into how ERT treats depression and to develop strategies to reduce depression in menopausal women. In turn, these findings may help categorize populations of women whose depression should be treated with ERT versus nonhormonal therapies. In this 9-week study, participants will be randomly assigned to receive ERT, a sleeping pill, or placebo. Study visits will occur at baseline and Weeks 2, 4, 6, and 9; at each study visit, blood pressure will be monitored, and standardized psychological tests and questionnaires will be used to assess the participant's level of depression and reported quality of life outcomes. Blood will be drawn at baseline and Week 9 to measure estrogen and follicle stimulating hormone levels.

Official Title
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Understanding the Role That Hot Flashes and Sleep Disruption Play in the Effect of Estrogen Replacement Therapy on Mood in Perimenopausal and Postmenopausal Women

Conditions
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Sleep Initiation and Maintenance Disorders, Depression

Intervention / Treatment
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* Drug: Estrogen Replacement Therapy
* Drug: Zolpidem
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Perimenopausal or postmenopausal status Surgical menopause or hysterectomy with one or both ovaries preserved if serum follicle stimulating hormone is greater than 20 IU/L Diagnosed with mild to moderate clinical depression Currently experiencing moderate to severe hot flashes Currently experiencing insomnia caused by nocturnal hot flashes Normal mammogram within the 2 years prior to study entry Willing to use an effective form of contraception throughout the study if perimenopausal and sexually active Exclusion Criteria: Current severe depression or history of severe depression within the 5 years prior to study entry Suicidal or homicidal ideation Psychotic symptoms History of any psychiatric disorder (e.g., psychosis, bipolar disorder, panic disorder, obsessive-compulsive disorder, or anorexia nervosa) History of any substance abuse (including alcohol abuse) within the 5 years prior to study entry Regular use of hormonal medications within the month prior to study entry Regular use of hypnotic drugs, antidepressants, or over-the-counter drugs known to influence hot flashes, sleep, or mood within the 2 weeks prior to study entry Intolerance to estrogen therapy or informed that estrogen therapy is medically inadvisable

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive estrogen replacement therapy | Drug: Estrogen Replacement Therapy<br>* 17-b-Estradiol Patch, .05 mg/day; applied for 7 days<br>* Other names: Climara;|
| Experimental: 2<br>Participants will receive treatment with zolpidem | Drug: Zolpidem<br>* 10 mg/day, po qhs<br>* Other names: Ambien;|
| Placebo Comparator: 3<br>Participants will receive treatment with placebo | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale |  | Measured at at baseline and Weeks 2, 4, 6, and 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life indicators; measured by the Quality of Life Inventory |  | Measured at at baseline and Weeks 2, 4, 6, and 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Women, Menopause, Depression, Hot flash, Insomnia, Sleep Disruption, Estrogen Replacement Therapy