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

Completed · Phase 4 · Has a placebo group

Conditions studied: Sleep Initiation and Maintenance Disorders, Depression

In brief

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

Key facts

Study ID

NCT00227942

Run by

Hadine Joffe, MD

People needed

86

Starts

2003-08-01

Expected to finish

2007-11-01

Last updated by the study team

2014-05-26

Who can join

Age: 40 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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