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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hadine Joffe, MD
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Estrogens; Zolpidem

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