Protocol Number: 00-M-0103

Title:

The Treatment of Menstrually-Related Mood Disorders with Continuous Gonadal Steroid Replacement

Number:

00-M-0103

Summary:

The purpose of this study is to investigate the role of the hormones estrogen and progesterone in women with premenstrual syndrome (PMS).

Studies indicate that women with PMS experience improvement in symptoms following treatment with leuprolide acetate, when estrogen and progesterone levels are low. Women with PMS, but not women without the disorder, experience a return of symptoms within approximately a week after re-exposure to either estrogen or progesterone. The cause of this hormone-induced depression remains unclear. It is not known whether this depressed mood is due simply to the change in the levels of estrogen and progesterone and whether it would remit following continued exposure to stable levels of estrogen and progesterone. This study will determine whether the maintenance of stable hormone levels will prevent mood disturbances in women with PMS.

Participants in this study will receive leuprolide acetate injections once a month for up to 6 months. After 2 months, women whose symptoms have improved will receive a skin patch containing either estrogen or placebo (an inactive substance) and will be asked to take daily suppositories containing either progesterone or placebo. Women whose symptoms of PMS do not respond to leuprolide treatment after 2 months will end the study and be offered other treatment. Participants will be seen by a nurse in the clinic every two weeks and will fill out ratings and have blood drawn to measure hormone levels.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility Criteria:

INCLUSION CRITERIA:

History within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity--i.e., disturbances that are distinct in appearance and associated with a notable degree of subjective distress and interference with life activities.

Symptoms with a sudden offset and absence of significant symptomatology during the follicular phase.

Age 18-50.

Regular menstrual cycles (21-35 days in length), not pregnant, and in good medical health.

Medication free.

No subjects taking birth control pills or psychotropic agents (e.g. Antidepressants, anxiolytics, or lithium carbonate).

EXCLUSION CRITERIA:

Any patient with a current axis I psychiatric diagnosis will be excluded.

Special Instructions:

Call referral contact for additional eligibility criteria.

Keywords:

Depression

Menstrual Cycle

Gonadal Steroids

GnRH Agonist

PMS

Estradiol

Progesterone

Mood

MRMD

PMDD

Recruitment Keywords:

Menstrually Related Mood Disorders

Conditions:

Premenstrual Syndrome

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Linda Simpson-St. Clair, R.N.
National Institutes of Health
Building 10
Room 3N238
10 Center Drive
Bethesda, Maryland 20892
Phone: (301) 496-9576
Fax: (301) 402-2588

Electronic Address: simpsonl@irp.nimh.nih.gov

Citations:

Changes in plasma hormones across the menstrual cycle in patients with menstrually related mood disorder and in control subjects

Differential behavioral effects of gonadal steroids in women with and in those without premenstrual syndrome

Lack of effect of induced menses on symptoms in women with premenstrual syndrome

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National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/28/2004