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

Sponsor

Hadine Joffe, MD (Other)

Overall Status

Completed

CT.gov ID

NCT00227942

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sleep Initiation and Maintenance Disorders Depression	Drug: Estrogen Replacement Therapy Drug: Zolpidem Drug: placebo	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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

Study Start Date :

Aug 1, 2003

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Participants will receive estrogen replacement therapy	Drug: Estrogen Replacement Therapy 17-b-Estradiol Patch, .05 mg/day; applied for 7 days Other Names: Climara
Experimental: 2 Participants will receive treatment with zolpidem	Drug: Zolpidem 10 mg/day, po qhs Other Names: Ambien
Placebo Comparator: 3 Participants will receive treatment with placebo	Drug: placebo placebo

Arm

Intervention/Treatment

Experimental: 1

Participants will receive estrogen replacement therapy

Drug: Estrogen Replacement Therapy

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

Other Names:

Climara

Experimental: 2

Participants will receive treatment with zolpidem

Drug: Zolpidem

10 mg/day, po qhs

Other Names:

Ambien

Placebo Comparator: 3

Participants will receive treatment with placebo

Drug: placebo

placebo

Outcome Measures

Primary Outcome Measures

Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale [Measured at at baseline and Weeks 2, 4, 6, and 9]

Secondary Outcome Measures

Quality of life indicators; measured by the Quality of Life Inventory [Measured at at baseline and Weeks 2, 4, 6, and 9]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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