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Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety) Clinical research trials and Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety) health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety). Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety) Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety) clinical trial. Test subjects typically receive the most expert healthcare available for their Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety) condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety)  Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety)
Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety)
For Condition: Depressive Disorder,Mood Disorder,Psychomotor Agitation
Status: Completed
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: Often women are prescribed hormone replacement therapy (HRT) during the perimenopause or menopause. Hormone replacement therapy includes both estrogen and progesterone. The estrogen component of HRT helps to relieve the symptoms and has a beneficial effect on the heart and bones, but estrogen also increases the risk of uterine cancer. The progesterone component of the HRT (progestin) works to prevent the increased risk of uterine cancer. There is evidence that some women experience unpleasant mood symptoms (such as irritability, depressed mood and anxiety) while receiving hormone replacement therapy (HRT) while taking the progestin / progesterone component of the HRT. This study is designed to evaluate the ability of progestins to produce negative mood symptoms in women. Researchers intend on doing this by comparing the effects of medroxyprogesterone acetate (Provera) and a placebo inactive sugar pill. Patient's moods will be monitered based on their response to questionnaires answered in the outpatient clinic and at home. This research will attempt to answer the following questions: 1. Are progestins associated with changes in mood during hormone replacement therapy? 2. If progestins are associated with mood disturbance, is it because they are blocking the beneficial effects of estrogen?
Details: There is evidence in the literature that some women experience dysphoric symptoms while receiving hormone replacement therapy (HRT) and that this disturbance in mood is related to the progestin component of the HRT. The bulk of this evidence is anecdotal. While some authors have attempted to examine this putative problem in a more systematic fashion, there are no controlled studies that attempt to identify the mechanism through which the perturbation in mood occurs. Adverse effects of progestins might be mediated directly through the progesterone or androgen receptor. Alternatively, the effects of progestins might be consequent to the antiestrogen effects of progesterone. This latter possibility is in part supported by our observation in previous studies of the beneficial effects of estradiol on mood and the possible precipitation of mood disturbance following acute estrogen withdrawal. Finally, despite the popular lore that progesterone causes mood disturbances, a placebo effect cannot be ruled out, since women taking HRT know when they are receiving the progestin component of the regimen. Our research questions therefore are as follows: 1) Are progestins associated with changes in mood during HRT, and 2) If progestins are associated with mood disturbance, is it because they are blocking the beneficial effects of estrogen?
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA The subjects in this study will be women who meet the following criteria: 1) history of mood and/or behavioral symptoms associated with hormone replacement therapy; 2) age 40 to 65; 3) in good medical health. EXCLUSION CRITERIA Any subject with significant physical, EKG, mammogram or laboratory abnormalities will not participate in this protocol. Additionally prior to participation all subjects will be examined for any contradictions to estrogen therapy (as determined by a pelvic exam and mammogram) within the past year by a gynecologist of their choice. In those patients who are unable to independently arrange this exam, we have arranged for a consultant gynecologist to be available through our collaboration with NICHD.
Total Enrollment: 50
Location and Contact Information:
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980079; 98-M-0079
Study Start Date: March 14, 1998
Record last reviewed: March 4, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001770
Other Mood Disorder Studies:
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2. Middle School to High School Transition Project
3. Qigong Therapy For Heart Device Patients
4. Treatment of Vascular Depression
5. Effects of Therapist Behavior on the Treatment of Depressed Adolescents
Related Studies:
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Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety)
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