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

NCT ID: NCT00227942

Last Updated: 2014-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2007-11-30

Brief Summary

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

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.

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Participants will receive estrogen replacement therapy

Group Type: EXPERIMENTAL

Estrogen Replacement Therapy

Intervention Type: DRUG

17-b-Estradiol Patch, .05 mg/day; applied for 7 days

2

Participants will receive treatment with zolpidem

Group Type: EXPERIMENTAL

Zolpidem

Intervention Type: DRUG

10 mg/day, po qhs

3

Participants will receive treatment with placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

Interventions

Estrogen Replacement Therapy

17-b-Estradiol Patch, .05 mg/day; applied for 7 days

Intervention Type: DRUG

Zolpidem

10 mg/day, po qhs

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Other Intervention Names

Climara; Ambien

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Hadine Joffe, MD

OTHER

Sponsor Role: lead

Responsible Party

Hadine Joffe, MD

Director of Research at the Center for Women's Mental Health

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hadine Joffe, MD, MSC

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

MGH Center for Perinatal and Women's Mental Health

Boston, Massachusetts, United States

Countries

United States

References

Galvan T, Camuso J, Sullivan K, Kim S, White D, Redline S, Joffe H. Association of estradiol with sleep apnea in depressed perimenopausal and postmenopausal women: a preliminary study. Menopause. 2017 Jan;24(1):112-117. doi: 10.1097/GME.0000000000000737.

Reference Type: DERIVED

PMID: 27648659 (View on PubMed)

Related Links

http://www.womensmentalhealth.org

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

Other Identifiers

K23MH066978

Identifier Type: NIH

Identifier Source: secondary_id

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DATR AK-TNAI1

Identifier Type: -

Identifier Source: secondary_id

K23MH066978

Identifier Type: NIH

Identifier Source: org_study_id

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