Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia (NCT00227942) | Clinical Trial Compass
CompletedPhase 4
Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia
United States86 participantsStarted 2003-08
Plain-language summary
This study will evaluate the effectiveness of estrogen replacement therapy in treating depression in menopausal women with hot flashes and insomnia.
Who can participate
Age range40 Years – 60 Years
SexFEMALE
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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
What they're measuring
1
Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale
Timeframe: Measured at at baseline and Weeks 2, 4, 6, and 9