This study is currently recruiting participants.
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)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Mental Health
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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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.
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.
Principal Investigator
Referral Contact
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