Protocol Number: 81-M-0126

Title:

The Phenomenology and Biophysiology of 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: Active Accrual Of New Subjects

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Eligibility Criteria:

INCLUSION CRITERIA:

The subjects of this study will be women who meet the following criteria: 1) 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 distant in appearance and associated with a notable degree of subjective distress; 2) 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; 3) age 18-50; 4) not pregnant and in good medical health; 5) regular menses.

EXCLUSION CRITERIA:

Subjects who do not meet the criteria listed above but who do not meet diagnosis criteria for recurrent brief depression will also be studied. The criteria for recurrent brief depression include the following: 1) dysphoric mood or loss of increase or pleasure; 2) duration less than two weeks; 3) four of the following symptoms: poor appetite weight gain; insomnia or hypersomnia; psychomotor agitation or retardation; loss of interest or pleasure in usual activities, or decrease in sexual desire; loss of energy; fatigue; feelings of worthlessness, self-reproach, or excessive or inappropriate guilt; diminished ability to think or concentrate, slowed thinking, or indecisiveness; 4) impairment in usual occupational activities; 5) at least one-two episodes per month over one year.

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 Keywords:

None

Conditions:

Mental Disorder

Mood Disorder

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

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

Citations:

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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Warren Grant Magnuson Clinical Center (CC)
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Bethesda, Maryland 20892. Last update: 10/23/2004