Status:
COMPLETED
Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia
Lead Sponsor:
Hadine Joffe, MD
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Sleep Initiation and Maintenance Disorders
Depression
Eligibility:
FEMALE
40-60 years
Phase:
PHASE4
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 physiologi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00227942
Start Date
August 1 2003
End Date
November 1 2007
Last Update
May 26 2014
Active Locations (1)
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1
MGH Center for Perinatal and Women's Mental Health
Boston, Massachusetts, United States, 02116