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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227942
• Other study ID #: K23MH066978
• Secondary ID: K23MH066978DATR
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2005
• Last updated: May 23, 2014
• Start date: August 2003
• Est. completion date: November 2007

Study information

• Verified date: May 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Hot Flashes
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
United States	MGH Center for Perinatal and Women's Mental Health	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Hadine Joffe, MD	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale		Measured at at baseline and Weeks 2, 4, 6, and 9	No
Secondary	Quality of life indicators; measured by the Quality of Life Inventory		Measured at at baseline and Weeks 2, 4, 6, and 9	No

External Links

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