The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
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⁃ 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.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Peter J Schmidt, M.D.
peterschmidt@mail.nih.gov
(301) 496-6120
Time Frame
Start Date: 1984-03-09
Participants
Target number of participants: 1600
Treatments
healthy volunteers
healthy females
patients
females with menstrually-related mood or behavioral difficulties
Sponsors
Leads: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov