Study of Premenstrual Syndrome and Premenstrual Dysphoria

Mood Disorder Clinical Trial

Official title: The Evaluation of Women With Menstrually Regulated Mood and Behavioral Disorders

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The purpose of this screening protocol is to identify a population of women who experience menstrually-related mood or behavior difficulties and to describe the symptoms in this group and their relationship to the menses. This will be accomplished by means of clinical interviews, self-rating scales, and periodic evaluation of mood and endocrine function. We further wish to identify and recruit a subgroup of women with menstrually-related mood disorder for participation in specific neuroendocrine/neurophysiologic studies (companion protocols) in an attempt to identify endocrinologic or physiologic measures that might: 1) be associated with the discrete changes in mood and behavior; 2) distinguish this group from a group of age-matched controls; 3) allow for further subgroup definition on the basis of predicted response to pharmacological intervention. Finally, we wish to identify a group of women with recurrent brief depression, who will serve as an additional control group for the patients with menstrual cycle-related mood disorders. ;

Related Conditions & MeSH terms

• Mood Disorder
• Mood Disorders
• Premenstrual Syndrome

• NCT number: NCT00001177
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Peter J Schmidt, M.D.
• Phone: (301) 496-6120
• Email: peterschmidt@mail.nih.gov
• Status: Recruiting
• Start date: March 9, 1984