|
The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression Clinical research trials and The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression. The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression clinical trial. Test subjects typically obtain the finest healthcare available for their The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression  The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression
The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression
For Condition: Perimenopause,Depression
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to investigate the effects of estrogen levels on perimenopausal depression. This study will examine short-term withdrawal of estrogen in women whose mood had improved with estrogen therapy. Perimenopause-related mood disorders cause significant distress in a large number of women. Evidence suggests that estradiol may have beneficial effects in women with perimenopausal depression. However, the effect of declining estradiol secretion during perimenopause has not been fully examined. Peri- and post-menopausal women who experience a remission of perimenopause-related depression symptoms while on estrogen therapy and a control group of healthy volunteers on hormone replacement therapy (HRT) will be switched from their current form of HRT to estradiol for a 3-week period; volunteers will also complete symptom ratings to confirm the absence of mood symptoms. Participants will then be randomly assigned to either continue estradiol or take a placebo (an inactive pill) for an additional 3 weeks. Mood ratings will be used to determine response to estradiol withdrawal.
Details: Perimenopause-related mood disorders cause significant distress to a potentially large number of women. Recent studies have reported the therapeutic benefits of estradiol in women with these mood disorders; however, a relevant pathophysiologic role of declining estradiol secretion during the perimenopause has not been demonstrated. In this protocol we wish to investigate the effects of acute withdrawal of estradiol on mood under placebo controlled conditions. Thus, mood and behavior symptoms may be precipitated by the experimental conditions of this protocol. This protocol will address the following hypothesis: women with a past history of perimenopause-related depression but not women without such a history will experience a recurrence of mood and behavioral symptoms during acute estradiol withdrawal but not during continued estradiol administration. The nature of the relationship between the declining secretion of estradiol and mood in perimenopausal depressed women will be examined as follows: Peri- and postmenopausal women reporting the onset of depression during the perimenopause and who report remission of depressive symptoms on estrogen therapy (ET) will be withdrawn from ET under blinded and placebo-controlled conditions. We will recruit as a comparison group asymptomatic women on hormone replacement and without a history of perimenopause-related depression. During a three week baseline phase, all women will be switched from their current form of hormone replacement therapy to estradiol and will complete symptom ratings to confirm the absence of mood symptoms prior to entry into the study. After the screening, all women will be randomized to receive either estradiol or placebo for an additional three weeks. Comparison of mood ratings during these contrasting treatment conditions will allow us to examine the specific role of estrogen withdrawal in depression that is responsive to ET.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA: Subjects for this study will meet the following criteria: Women with a recent (within the last 12 years) past history of perimenopause-related depression and whose depression responded to ET will be recruited to participate in this randomized, parallel-design, double-blind, placebo-controlled study. The diagnosis of perimenopause-related depression will be based on a history of a past depressive episode (major or minor depression confirmed by SCID or SADS-L, respectively) at midlife association with menstrual cycle irregularity and the history of remission (also confirmed by SCID or SADS-L) of this depression after ET. Additionally, all women will report that they were placed on HRT for the treatment of perimenopausal symptoms, including depression. To control for the effects of the hormonal manipulations in this protocol, we will also recruit a group of asymptomatic controls on ET and with no previous history of perimenopause-related depression or HRT-induced dysphoria. Age 45 to 60; In good medical health. The women participating in this protocol will have their reproductive status evaluated and documented. Perimenopausal reproductive status will be defined by a history of at least 6 months of menstrual cycle irregularity and biological evidence of ovarian dysfunction, specifically three of four plasma FSH values greater than 14IU/L on consecutive occasions drawn at two week intervals over a period of eight weeks (total of four blood samples.) During the initial screening period, a complete history, physical examination, and EKG will be performed on all subjects, and the following lab data will be obtained: Blood-complete blood count; electrolytes; glucose, BUN and creatinine; liver function tests; thyroid function tests, prolactin, and lipid profile. Urine-urinalysis; plasma beta HCG pregnancy test. Any subject with significant physical, EKG, or laboratory abnormalities, or who meets any of the exclusion criteria will not participate in this protocol. Additionally, prior to participation all subjects will be examined for any contraindications to ET. Women will be examined by a gynecologist of their choice. EXCLUSION CRITERIA: Women with histories of either perimenopausal depression that are not responsive to ET or hormone replacement therapy-induced dysphoria due to either the estrogen or the progesterone components of their hormone replacement will be excluded. The following will constitute contraindications to participate in this protocol: past history of severe major depression with suicidal ideation current treatment with antidepressant medications history of ischemic cardiac disease, pulmonary embolism, or thrombophlebitis renal disease hepatic dysfunction women with a history of carcinoma of the breast women with a history of uterine cancer, ill-defined pelvic lesions, particularly undiagnosed ovarian enlargement, undiagnosed vaginal bleeding pregnant women cerebrovascular disease (stroke) recurrent migraine headaches
Total Enrollment: 60
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030175; 03-M-0175
Study Start Date: May 5, 2003
Record last reviewed: March 9, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060736
Other Depression Studies:
1. The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression
Related Studies:
Other Depression Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression
|
|
|
|
|
|
|
|
