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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00227942
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : May 26, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Hadine Joffe, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE September 26, 2005
First Posted Date  ICMJE September 28, 2005
Last Update Posted Date May 26, 2014
Study Start Date  ICMJE August 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2008)
Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale [ Time Frame: Measured at at baseline and Weeks 2, 4, 6, and 9 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale at baseline and Weeks 2, 4, 6, and 9
Change History Complete list of historical versions of study NCT00227942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2008)
Quality of life indicators; measured by the Quality of Life Inventory [ Time Frame: Measured at at baseline and Weeks 2, 4, 6, and 9 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
Quality-of-life; measured by the Quality of Life Inventory at baseline and Weeks 2, 4, 6, and 9
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia
Official Title  ICMJE Understanding the Role That Hot Flashes and Sleep Disruption Play in the Effect of Estrogen Replacement Therapy on Mood in Perimenopausal and Postmenopausal Women
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Initiation and Maintenance Disorders
  • Depression
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Galvan T, Camuso J, Sullivan K, Kim S, White D, Redline S, Joffe H. Association of estradiol with sleep apnea in depressed perimenopausal and postmenopausal women: a preliminary study. Menopause. 2017 Jan;24(1):112-117. doi: 10.1097/GME.0000000000000737.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2008)
86
Original Enrollment  ICMJE
 (submitted: September 26, 2005)
91
Actual Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00227942
Other Study ID Numbers  ICMJE K23MH066978( U.S. NIH Grant/Contract )
K23MH066978 ( U.S. NIH Grant/Contract )
DATR AK-TNAI1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hadine Joffe, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Hadine Joffe, MD
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Hadine Joffe, MD, MSC Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2014

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