Perimenopause-Related Mood and Behavioral Disorders
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|ClinicalTrials.gov Identifier: NCT00001231|
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : April 13, 2020
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||1900 participants|
|Official Title:||The Evaluation of Women With Perimenopause-Related Mood and Behavioral Disorders|
|Actual Study Start Date :||July 12, 1988|
The purpose of this protocol is to allow for the careful screening of healthy volunteers for participation in research protocols.
premenopausal depressed women patients
The purpose of this protocol is to allow for the careful screening of patients for participation in research protocols.
- Standardized cross sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Center for Epidemiologic Studies-Depression Scale), symptom rating scales completed daily, and plasma hormone measures (includ... [ Time Frame: ongoing ]Standardized cross-sectional rating scales (Beck Depression Inventory, Hamilton Depression and Anxiety Scales, and the Center for Epidemiologic Studies-Depression Scale), symptom rating scales completed daily, and plasma hormone measures (including neurosteroid levels).
- Plasma ACTH and cortisol response to the o-CRH stimulation tests, selected variants in genomic profile (e. g., SNPs) and genome/exome sequencing, and the results of the SCID interviews [ Time Frame: ongoing ]Plasma ACTH and cortisol response to the o-CRH stimulation tests, selected variants in genomic profile (e. g., SNPs) and genome/exome sequencing, and the results of the SCID interviews
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001231
|Contact: Peter J Schmidt, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Peter J Schmidt, M.D.||National Institute of Mental Health (NIMH)|