|
Perimenopause-Related Mood and Behavioral Disorders 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 Perimenopause-Related Mood and Behavioral Disorders conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Perimenopause-Related Mood and Behavioral Disorders Clinical research trials and Perimenopause-Related Mood and Behavioral Disorders 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 Perimenopause-Related Mood and Behavioral Disorders. Perimenopause-Related Mood and Behavioral Disorders 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 Perimenopause-Related Mood and Behavioral Disorders clinical trial. Test subjects typically receive the most expert healthcare available for their Perimenopause-Related Mood and Behavioral Disorders 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.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Perimenopause-Related Mood and Behavioral Disorders  Perimenopause-Related Mood and Behavioral Disorders
Perimenopause-Related Mood and Behavioral Disorders
For Condition: Depressive Disorder,Healthy
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to investigate mood and behavior changes in the time period surrounding and including menopause. This is an observational study; volunteers who participate will not receive any new or experimental therapies. Controversy exists regarding the relationship between estrogen and progesterone (gonadal steroid) changes and midlife-onset depression. This study will examine the role of gonadal steroids in perimenopausal mood and behavioral disorders. Perimenopausal women with depression symptoms and a control group of healthy perimenopausal volunteers will be compared to identify correlates of the occurrence of depression. Participants with depressive symptoms may also participate in companion studies that will test the antidepressant efficacy of phytoestrogens and selective estrogen receptor modulators (SERMS). A group of younger pre-perimenopausal women with normal menstrual cycle functioning will be followed through menopause in an effort to confirm the association of depression onset with changes in reproductive endocrine functioning.
Details: Controversy exists regarding the relevance of changes in gonadal steroids for midlife onset depressions. In this protocol, we examine the possible role of gonadal steroids in these disorders in two ways. First, we identify groups of both depressed and asymptomatic women who are in the perimenopause (as defined endocrinologically). Patients and controls are compared using baseline biological and phenomenological (e.g. life events, hot flushes) measures in an attempt to identify potentially meaningful correlates of the occurrence of depression. Patient subjects also serve as participants in companion protocols designed to identify the antidepressant efficacy of estradiol and DHEA administration. Second, we identify younger preperimenopausal women with normal menstrual cycle function, who are followed longitudinally through the menopause in an effort to confirm the association of depression onset with change in reproductive endocrine function. This protocol, then, serves as a screening protocol to recruit subjects who are characterized with standard measures in this protocol and then offered participation in related studies
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: PATIENT/VOLUNTEER ENROLLMENT CROSS-SECTIONAL SCREENING: INCLUSION CRITERIA Female. History within the last one year of at least one month with perimenopause or midlife-related mood or behavioral disturbances of at least moderate severity - that is, disturbances that are distinct in appearance and associated with a notable degree of functional impairment; Age 40-60; History of the onset of menstrual irregularity during the past six months but not greater than one year of amenorrhea (i.e., not postmenopausal); Biological evidence of a deterioration of normal ovarian activity, specifically, plasma FSH levels persistently elevated (greater than 14 IU/L) drawn at two week intervals over a period of eight weeks; No prior estrogen replacement therapy for treatment of perimenopausal physical or emotional symptoms within the last six months. Good medical health CONTROL GROUP A control group of age-matched perimenopausal women who meet patient selection criteria with the exception of the presence of mood or behavioral disorders will also be sought. LONGITUDINAL SCREENING: The pre-perimenopausal women (regular cycling) will be women who meet the following criteria: Female. Regular menstrual cycle function (21-34 days), Absence of current mood or behavioral disturbances as determined by a structured diagnostic interview, Early follicular phase plasma gonadotropin levels in pre-perimenopausal range (less than 14 IU/L), In good medical health, Medication free.
Total Enrollment: 600
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Linda Clair 3014969576
Additional Information:
Study ID Numbers: 880131; 88-M-0131
Study Start Date: July 12, 1988
Record last reviewed: July 15, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001231
Other Healthy Studies:
1. The Effect of Acetylcholine on Memory and Attention
2. Genetic Influence on Susceptibility to Type 1 Diabetes Mellitus
3. Adolescence, Puberty, and Emotion Regulation
4. Magnetic Resonance Imaging for the Study of Patients with Neurological Disorders
5. Comparison of Externally and Self-Initiated Movements
Related Studies:
Other Healthy Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Perimenopause-Related Mood and Behavioral Disorders
|
|
|
|
|
|
|
|
