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

Condition(s) targeted: Sleep Initiation and Maintenance Disorders; Depression

Intervention: Estrogen Replacement Therapy (Drug); Zolpidem (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
Hadine Joffe, MD, MSC, Principal Investigator, Affiliation: Massachusetts General Hospital

This study will evaluate the effectiveness of estrogen replacement therapy in 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale

Secondary outcome: Quality of life indicators; measured by the Quality of Life Inventory

Detailed 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.

Minimum age: 40 Years. Maximum age: 60 Years. Gender(s): Female.

Criteria:

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

MGH Center for Perinatal and Women's Mental Health, Boston, Massachusetts 02116, United States

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

Starting date: August 2003
Ending date: November 2007
Last updated: March 3, 2008