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临床试验/NCT00227942
NCT00227942已完成4 期

Understanding the Role That Hot Flashes and Sleep Disruption Play in the Effect of Estrogen Replacement Therapy on Mood in Perimenopausal and Postmenopausal Women

Hadine Joffe, MD1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2003年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

1

Experimental

Participants will receive estrogen replacement therapy

干预措施: Estrogen Replacement Therapy (Drug)

2

Experimental

Participants will receive treatment with zolpidem

干预措施: Zolpidem (Drug)

3

Placebo Comparator

Participants will receive treatment with placebo

干预措施: placebo (Drug)

结局指标

主要结局

Improvement of mood; measured by the Montgomery-Asberg Depression Rating Scale

时间窗: Measured at at baseline and Weeks 2, 4, 6, and 9

次要结局

  • Quality of life indicators; measured by the Quality of Life Inventory(Measured at at baseline and Weeks 2, 4, 6, and 9)

研究者

发起方
Hadine Joffe, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hadine Joffe, MD

Director of Research at the Center for Women's Mental Health

Massachusetts General Hospital

研究点 (1)

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