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

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”

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

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.

Intervention(s) in this Clinical Trial

• Drug: Estrogen Replacement Therapy
  • 17-b-Estradiol Patch, .05 mg/day; applied for 7 days
• Drug: Zolpidem
  • 10 mg/day, po qhs
• Drug: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants will receive estrogen replacement therapy
• Experimental: 2
  • Participants will receive treatment with zolpidem
• Placebo Comparator: 3
  • Participants will receive treatment with placebo

Primary Measures

• Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale
  • Time Frame: Measured at at baseline and Weeks 2, 4, 6, and 9
    Safety Issue?: No

Secondary Measures

• Quality of life indicators; measured by the Quality of Life Inventory
  • Time Frame: Measured at at baseline and Weeks 2, 4, 6, and 9
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: National Institute of Mental Health (NIMH) NIH

Overall Clinical Trial Officials and Contacts

Hadine Joffe, MD, MSC Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00227942

Study ID Number: K23 MH66978

ClinicalTrials.gov Identifier: NCT00227942

Health Authority: United States: Federal Government

Click here for the Massachusetts General Hospital Center for Women's Mental Health web site.