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Protocol Details

The Evaluation of Women with Menstrually Regulated Mood and Behavioral Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

81-M-0126

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Female
Min Age: 18 Years
Max Age: 50 Years

Referral Letter Required

No

Population Exclusion(s)

Male;
Children

Keywords

Cognition;
Neuroendocrine;
PMS Premenstrual Syndrome;
MRMD Menstrually Related Mood Disorder;
Menstrual

Recruitment Keyword(s)

None

Condition(s)

Mood Disorder

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Mental Health

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.

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Eligibility

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.

For subjects with recurrent brief depression:

-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 for all study participants:

-Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder);

-Current antidepressant therapy (since this is a screening protocol for subsequent treatment and physiologic evaluation studies in which participants must be untreated). Antidepressants will not be withheld from participants who need or want them;

-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).

-Pregnant or lactating women

-Subjects who are unable to provide informed consent

-NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy.


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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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Contacts:

Principal Investigator

Referral Contact

For more information:

Peter J. Schmidt, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CLINICAL CENTER BG RM 4C404
10 CENTER DR
BETHESDA MD 20892
(301) 496-6120
peterschmidt@mail.nih.gov

Peter J. Schmidt, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CLINICAL CENTER BG RM 4C404
10 CENTER DR
BETHESDA MD 20892
(301) 496-6120
peterschmidt@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00001177

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