Study of Premenstrual Syndrome and Premenstrual Dysphoria

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001177
First received: November 3, 1999
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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
PMS
Premenstrual Mood Disorder
PMDD
Depression

Study Type: Observational
Official Title: The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1600
Study Start Date: August 1981
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

The subjects of this study will be women who meet the following criteria:

  • history within the last two years of at least six months with menstrually-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 subjective distress;
  • a 30% increase in mean negative mood ratings (relative to the range of the scale employed) in the premenstrual week compared with the week following the end of menses in at least two of three cycles;
  • age 18 to 50;
  • not pregnant and in good medical health;
  • regular menses.

Subjects who do not meet the criteria listed above but who do meet diagnostic criteria for recurrent brief depression will also be studied. The criteria for recurrent brief depression include the following:

  • dysphoric mood or loss of interest or pleasure;
  • duration less than two weeks;
  • four of the following symptoms: poor appetite or significant weight loss (when not dieting) or increased appetite or significant weight gain; insomnia or hypersomnia; psychomotor agitation or retardation; loss of interest or pleasure in usual activities, or decrease in sexual drive; loss of energy; fatigue; feelings of worthlessness, self-reproach, or excessive or inappropriate guilt; diminished ability to think or concentrate, slowed thinking, or indecisiveness;
  • impairment in usual occupational activities;
  • at least one-two episodes per month over one year.

Age-matched women without mood and behavioral disorders will be recruited.

EXCLUSION CRITERIA:

Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder);

Current alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001177

Contacts
Contact: Peter J Schmidt, M.D. (301) 496-6120 peterschmidt@mail.nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Peter J Schmidt, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001177     History of Changes
Other Study ID Numbers: 810126, 81-M-0126
Study First Received: November 3, 1999
Last Updated: May 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Mood
Depression
Cognition
Menstrual
Neuroendocrine
Genetics
PMDD
PMS Premenstrual Syndrome
MRMD Menstrually Related Mood Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Disease
Mood Disorders
Premenstrual Syndrome
Behavioral Symptoms
Mental Disorders
Pathologic Processes
Menstruation Disturbances

ClinicalTrials.gov processed this record on October 01, 2014