Protocol Number: 03-M-0138

Title:

A Screening Protocol to Evaluate Women with Postpartum-Related Mood and Behavioral Disorders

Number:

03-M-0138

Summary:

The purpose of this study is to explore the relationship between mood and hormones in women with postpartum depression (PPD). This is an observational study; volunteers who participate will not receive any new or experimental therapies.

PPD is similar to major depression, but develops around the time a woman gives birth. Women with PPD often suffer serious physical and emotional impairments. Controversy exists regarding the role of hormone changes in postpartum depression. This study will examine the role of hormone changes in three groups of women: those who recently gave birth and have mild to moderately severe PDD (Group 1), women who recently gave birth and do not have PDD (Group 2), and those who are currently pregnant and experienced an episode of PDD with a previous birth (Group 3).

Participants will be screened with a medical history, physical examination, and blood and urine tests. Upon study entry, they will be interviewed about their moods, behaviors, and medical status during and immediately following their last pregnancy. Some women will be asked to participate in interviews, psychological tests, and blood tests. They will also complete self-rating scales and may be asked to collect samples of their urine. Women in Group 3 will complete self-rating scales for 6 months postpartum. Participants will participate in genetic studies that involve completing a questionnaire and providing a blood sample. If the participant allows, sisters and parents may be asked to provide a blood sample and undergo a psychiatric interview.

Participants who meet the criteria for minor depression or major depression that is no greater than moderate severity will be asked to participate in a companion study that will evaluate the effectiveness of estriadol in reducing depression symptoms.

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:

IINCLUSION CRITERIA:

A/Cross-sectional Screening: The postpartum subjects of this protocol will be women who meet the following criteria: 1) history within the last six months of at least two weeks with postpartum-related mood or behavioral disturbances of at least moderate severity - that is, disturbances that are distinct in appearance and associated with a mild to moderate degree of functional impairment; 2) the onset of mood symptoms occurred within three months of delivery ; 3) age 20 -45; 4) history of normal delivery (vaginal or caesarean) within the last seven months; 5) no prior estrogen replacement therapy for treatment of postpartum physical or emotional symptoms within the last six months; and 6) in good medical health. A control group of age-matched postpartum women who meet patient selection criteria with the exception of the presence of mood or behavioral disorders will also be sought.

All subjects who will be asked to participate in one of the companion protocols evaluating the efficacy of estriadol will meet either research diagnostic criteria for minor depression with at least three core symptoms (SADS-L (39) or major depression (SCID-IV) (40) of not greater than moderate severity on the GAF (40)) and will not meet DSM-IV criteria # 9 (suicide) or require immediate treatment. Subjects meeting major depression with greater than moderate severity may undergo screening but will be offered a referral to an outside facility for standard antidepressant treatment.

B/Longitudinal Screening: The at risk pregnant women will be women who meet the following criteria: 1) pregnant; 2) absence of current mood or behavioral disturbance as determined by a structured diagnostic interview; 3) past history of postpartum depression; 4) in good medical health, and 5) medication free.

Special Instructions: Currently Not Provided

Keywords:

Puerperium

Pregnancy

Mood Disorders

Estradiol

Progesterone

Mood

Behavior

Cognition

Perimenopause

Menopause

Recruitment Keywords:

Post Partum Depression

PPD

Healthy Volunteer

HV

Conditions:

Postpartum Depression

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Kumar R, Robson KM. A prospective study of emotional disorders in childbearing women. Br J Psychiatry. 1984 Jan;144:35-47. PMID: 6692075

Cox JL, Murray D, Chapman G. A controlled study of the onset, duration and prevalence of postnatal depression. Br J Psychiatry. 1993 Jul;163:27-31. PMID: 8353695

O'Hara MW, Schlechte JA, Lewis DA, Varner MW. Controlled prospective study of postpartum mood disorders: psychological, environmental, and hormonal variables. J Abnorm Psychol. 1991 Feb;100(1):63-73. PMID: 2005273

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/15/2004