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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00227942 |
Purpose
This study will evaluate the effectiveness of estrogen replacement therapy in treating depression in menopausal women with hot flashes and insomnia.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Initiation and Maintenance Disorders Depression |
Drug: Estrogen Replacement Therapy Drug: Zolpidem Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Understanding the Role That Hot Flashes and Sleep Disruption Play in the Effect of Estrogen Replacement Therapy on Mood in Perimenopausal and Postmenopausal Women |
| Enrollment: | 86 |
| Study Start Date: | August 2003 |
| Study Completion Date: | November 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive estrogen replacement therapy
|
Drug: Estrogen Replacement Therapy
17-b-Estradiol Patch, .05 mg/day; applied for 7 days
Other Name: Climara
|
|
Experimental: 2
Participants will receive treatment with zolpidem
|
Drug: Zolpidem
10 mg/day, po qhs
Other Name: Ambien
|
|
Placebo Comparator: 3
Participants will receive treatment with placebo
|
Drug: placebo
placebo
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| MGH Center for Perinatal and Women's Mental Health | |
| Boston, Massachusetts, United States, 02116 | |
| Principal Investigator: | Hadine Joffe, MD, MSC | Massachusetts General Hospital |
More Information
| Responsible Party: | Hadine Joffe, MD, MSc, Perinatal and Reproductive Psychiatry Program |
| ClinicalTrials.gov Identifier: | NCT00227942 History of Changes |
| Other Study ID Numbers: | K23 MH66978, DATR AK-TNAI1 |
| Study First Received: | September 26, 2005 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
|
Women Menopause Depression Hot flash |
Insomnia Sleep Disruption Estrogen Replacement Therapy |
|
Depression Depressive Disorder Sleep Initiation and Maintenance Disorders Hot Flashes Behavioral Symptoms Mood Disorders Mental Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Signs and Symptoms Estrogens Zolpidem |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Hypnotics and Sedatives Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |