Study of Premenstrual Syndrome and Premenstrual Dysphoria

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Keywords

ClinConnect Summary

This clinical trial is studying premenstrual syndrome (PMS) and its more severe form, called premenstrual dysphoric disorder (PMDD). The goal is to better understand the symptoms women experience before their periods and how these symptoms affect their mood and behavior. Women who have experienced significant mood changes related to their menstrual cycle may be eligible to participate. To qualify, they need to be between 18 and 50 years old, have regular menstrual cycles, and have noticed mood disturbances for at least six months in the past two years.

Participants in the study will take part in interviews and complete questionnaires about their moods. Some women with severe PMS may also be invited to join additional studies that look at hormonal changes, treatments for PMS symptoms, or genetic factors related to PMS. The study is currently recruiting participants, and those who join can expect to contribute to important research that could help improve understanding and treatment of PMS and mood disorders in the future.

Gender

FEMALE

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.
• 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.