Protocol Number: 81-M-0126

Title:

The Evaluation of Women with Menstrually Regulated Mood and Behavioral Disorders

Number:

81-M-0126

Summary:

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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility 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).

Special Instructions:

Call referral contact for additional eligibility criteria.

Keywords:

Mood

Depression

Cognition

Menstrual

Neuroendocrine

Genetics

PMDD

PMS Premenstrual Syndrome

MRMD Menstrually Related Mood Disorder

Recruitment Keyword(s):

None

Condition(s):

PMS

Premenstrual Mood Disorder

PMDD

Depression

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Mental Health

Contact(s):

Linda Simpson-St. Clair, R.N.
National Institutes of Health
Building 10
Room 3N238
10 Center Drive
Bethesda, Maryland 20892
Phone: (301) 496-9576
Fax: (301) 402-2588
Electronic Address: simpsonl@irp.nimh.nih.gov

Citation(s):

The premenstrual syndrome: new views

Differential behavioral effects of gonadal steroids in women with and in those without premenstrual syndrome

The premenstrual syndrome - a reappraisal of the concept and the evidence

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