Study of Premenstrual Syndrome and Premenstrual Dysphoria
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00001177|
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : May 30, 2019
The purpose of this study is to identify and describe the symptoms of premenstrual syndrome (PMS).
Women who experience PMS symptoms will complete clinical interviews, self-rating scales, and evaluations of mood and endocrine function. A subgroup of women with severe PMS (Premenstrual Dysphoric Disorder or PMDD) will be offered additional research studies that focus on: 1) identifying the endocrine changes that may be responsible for changes in mood and behavior during the premenstrual period, 2) evaluating treatments for PMS symptoms, and/or 3) identifying genetic factors in women with and without PMS. Women with recurrent brief depression will also be recruited to serve as a comparison group.
|Condition or disease|
|PMS Premenstrual Mood Disorder PMDD Depression|
The relevance of changes in ovarian steroids in the pathophysiology of menstrually-regulated mood disorders (MRMD [the term Premenstrual Dysphoria (PMD) will be employed in the text instead of MRMD] remains to be fully characterized. The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols that examine the role of gonadal steroids in PMD and for the collection of natural history data. Women in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; daily symptom rating scales; a medical history; a physical exam; blood and urine laboratory evaluation; and a request for medical records. The data collected may also be linked with data from other PMD protocols (e.g., DNA, psychophysiology tests, treatment studies, etc.) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of women with PMD. Upon conclusion of the evaluation process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community.
Finally, we wish to identify a group of women with recurrent brief depression, who will serve as an additional control group for the patients with menstrual cycle-related mood disorders. This protocol, then, serves as a screening and evaluation protocol to recruit subjects who are characterized with standard measures in this protocol and then offered participation in related studies.
|Study Type :||Observational|
|Estimated Enrollment :||1600 participants|
|Official Title:||The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders|
|Actual Study Start Date :||August 24, 1981|
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): NCT00001177
|Contact: Peter J Schmidt, M.D.||(301) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Peter J Schmidt, M.D.||National Institute of Mental Health (NIMH)|