Home
 
       

Study of Premenstrual Syndrome and Premenstrual Dysphoria

This study is currenly Recruiting patients.
Sponsored by: National Institute of Mental Health (NIMH)

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.
Study Type: Treatment
Condition Treatment Phase
PMS
Premenstrual Mood Disorder
PMDD
Depression
None N/A
Study Design:N/A
Official Title: The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders
Further Study Details:
Expected Total Enrollment:
Study Dates:August 1981 -
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- Min: 18 Years Max: 50 Years
Gender: Female
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).

  • Location and Contact Information
    Please refer to this study by ClinicalTrials.gov identifier: NCT00001177
    Maryland
    National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda, Maryland 20892

    More Information
    Record Last Reviewed:June 2010
    Last Updated:July 10, 2010
    Record First Recieved:November 3, 1999
    ClinicalTrials.gov Identifier:NCT00001177
    Health Authority: United States Food and Drug Administration
    Information obtained from ClinicalTrials.gov on September 08, 2010

    footer Lib
      Last Modified:
    Questions or comments? Please contact our Webmaster.
    About Us, Terms of UsePrivacy Policy, Medical Board
    © NCERx LLC 2005. All rights reserved.