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Study of Premenstrual Syndrome and Premenstrual Dysphoria

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ClinicalTrials.gov Identifier: NCT00001177
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : July 19, 2017
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

November 3, 1999
November 4, 1999
July 19, 2017
August 24, 1981
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Complete list of historical versions of study NCT00001177 on ClinicalTrials.gov Archive Site
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Study of Premenstrual Syndrome and Premenstrual Dysphoria
The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders

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.

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.

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  • PMS
  • Premenstrual Mood Disorder
  • PMDD
  • Depression
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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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.


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).

Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Contact: Peter J Schmidt, M.D. (301) 496-6120 peterschmidt@mail.nih.gov
United States
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National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
National Institute of Mental Health (NIMH)
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Principal Investigator: Peter J Schmidt, M.D. National Institute of Mental Health (NIMH)
National Institutes of Health Clinical Center (CC)
July 7, 2017