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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Hadine Joffe, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00227942
First received: September 26, 2005
Last updated: May 23, 2014
Last verified: May 2014

September 26, 2005
May 23, 2014
August 2003
Not Provided
Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale [ Time Frame: Measured at at baseline and Weeks 2, 4, 6, and 9 ] [ Designated as safety issue: No ]
Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale at baseline and Weeks 2, 4, 6, and 9
Complete list of historical versions of study NCT00227942 on ClinicalTrials.gov Archive Site
Quality of life indicators; measured by the Quality of Life Inventory [ Time Frame: Measured at at baseline and Weeks 2, 4, 6, and 9 ] [ Designated as safety issue: No ]
Quality-of-life; measured by the Quality of Life Inventory at baseline and Weeks 2, 4, 6, and 9
Not Provided
Not Provided
 
Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia
Understanding the Role That Hot Flashes and Sleep Disruption Play in the Effect of Estrogen Replacement Therapy on Mood in Perimenopausal and Postmenopausal Women

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Sleep Initiation and Maintenance Disorders
  • Depression
  • Drug: Estrogen Replacement Therapy
    17-b-Estradiol Patch, .05 mg/day; applied for 7 days
    Other Name: Climara
  • Drug: Zolpidem
    10 mg/day, po qhs
    Other Name: Ambien
  • Drug: placebo
    placebo
  • Experimental: 1
    Participants will receive estrogen replacement therapy
    Intervention: Drug: Estrogen Replacement Therapy
  • Experimental: 2
    Participants will receive treatment with zolpidem
    Intervention: Drug: Zolpidem
  • Placebo Comparator: 3
    Participants will receive treatment with placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
November 2007
Not Provided

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
Female
40 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00227942
K23 MH66978, K23MH066978, DATR AK-TNAI1
No
Hadine Joffe, MD, Massachusetts General Hospital
Hadine Joffe, MD
National Institute of Mental Health (NIMH)
Principal Investigator: Hadine Joffe, MD, MSC Massachusetts General Hospital
Massachusetts General Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP