Trial record 1 of 97 for:    estrogen replacement therapy
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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
  Purpose

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


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Depression
Drug: Estrogen Replacement Therapy
Drug: Zolpidem
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Understanding the Role That Hot Flashes and Sleep Disruption Play in the Effect of Estrogen Replacement Therapy on Mood in Perimenopausal and Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 86
Study Start Date: August 2003
Study Completion Date: November 2007
Arms Assigned Interventions
Experimental: 1
Participants will receive estrogen replacement therapy
Drug: Estrogen Replacement Therapy
17-b-Estradiol Patch, .05 mg/day; applied for 7 days
Other Name: Climara
Experimental: 2
Participants will receive treatment with zolpidem
Drug: Zolpidem
10 mg/day, po qhs
Other Name: Ambien
Placebo Comparator: 3
Participants will receive treatment with placebo
Drug: placebo
placebo

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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227942

Locations
United States, Massachusetts
MGH Center for Perinatal and Women's Mental Health
Boston, Massachusetts, United States, 02116
Sponsors and Collaborators
Hadine Joffe, MD
Investigators
Principal Investigator: Hadine Joffe, MD, MSC Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Hadine Joffe, MD, Director of Research at the Center for Women's Mental Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00227942     History of Changes
Other Study ID Numbers: K23 MH66978, K23MH066978, DATR AK-TNAI1
Study First Received: September 26, 2005
Last Updated: May 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Women
Menopause
Depression
Hot flash
Insomnia
Sleep Disruption
Estrogen Replacement Therapy

Additional relevant MeSH terms:
Estrogens
Depression
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Hot Flashes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms
Zolpidem
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014