Protocol Number: 95-M-0097

Title:

An Endocrine Model For Postpartum Mood Disorders

Number:

95-M-0097

Summary:

The purpose of this study is to determine how women who have experienced a postpartum mood disorder respond to estrogen and progesterone in comparison to women who have had an episode of major depression not related to PPD, and in comparison with women who have not experienced mood disorders.

Mood and behavioral disturbances during pregnancy and following delivery affect a large group of women, yet the causes of postpartum disorder (PPD) remain undetermined. Previous studies suggest that women with menstrual cycle-related mood disorders experience mood disturbances when the gonadal hormones estrogen and progesterone are replaced. This study will determine whether the abrupt withdrawal of, or prolonged exposure to, gonadal hormones is associated with mood disturbances.

This study will use the drug leuprolide acetate to simulate a hormonal state of pregnancy and the 6-week period following delivery in both women who have experienced a postpartum mood disorder and those who have not. Participants will be given leuprolide acetate at the beginning of the study. Participants will then receive estradiol and progesterone for 8 weeks. After 8 weeks, administration of estradiol and progesterone will be stopped in one group of participants; the other group will continue taking estrogen and progesterone for an additional month. Mood symptoms and hormone levels will be measured throughout the study.

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

Eligibility Criteria:

INCLUSION CRITERIA:

The subjects of this study will be women who meet the following criteria:

A history of DSM-IV major depression or hypomanic/manic episode that occurred within three months of childbirth;

Has been well for a minimum of one year;

A regular menstrual cycle for at least three months;

Age 18-40;

Not be pregnant, not lactating and in good medical health;

Medication free, including birth control pills;

No history of suicide attempts or psychotic episodes requiring hospitalization.

EXCLUSION CRITERIA:

Any women with a current axis I psychiatric diagnosis.

Women with specific medical conditions or histories will also be excluded.

Special Instructions:

None

Keywords:

Postpartum Disorders

Depression

Mood

Postpartum Depression

Hormones

Pregnancy

Estrogen

Progesterone

Recruitment Keywords:

Postpartum Depression

Depression

Postpartum

Mood Disorder

Conditions:

Depressive Disorder

Mood Disorder

Postpartum Depression

Investigational Drug(s):

Lupron

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:

A controlled study of the onset, duration and prevalence of postnatal depression

Effects of gonadal steroids in women with a history of postpartum depression

Transdermal oestrogen for treatment of severe postnatal depression

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