Study of Premenstrual Syndrome and Premenstrual Dysphoria

Conditions Phase Intervention Type
N/A

Eligibility

Ages Eligible for Study
18 years to 50 years
Genders Eligible for Study
F

Keywords

Mood, Depression, Cognition, Menstrual, Neuroendocrine, Genetics, PMDD, PMS Premenstrual Syndrome, and MRMD Menstrually Related Mood Disorder

Sponsors

NIH
National Institute of Mental Health (NIMH)

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).

Detailed Description

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.

Contacts and Locations

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

Overall Contact Backup

Peter J Schmidt, M.D.
(301) 496-6120

Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland United States

    Status: Recruiting

    Contact info For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
    800-411-1222xTTY8664111010