Screening Evaluation for Women With Postpartum Depression
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|ClinicalTrials.gov Identifier: NCT00056901|
Recruitment Status : Terminated
First Posted : March 26, 2003
Last Update Posted : February 14, 2018
This study evaluates the relationship between mood changes 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 estradiol in reducing depression symptoms.
|Condition or disease|
|Postpartum Depression Depression|
|Study Type :||Observational|
|Actual Enrollment :||68 participants|
|Official Title:||A Screening Protocol to Evaluate Women With Postpartum-Related Mood and Behavioral Disorders|
|Study Start Date :||March 25, 2003|
|Estimated Study Completion Date :||December 24, 2017|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056901
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Peter J Schmidt, M.D.||National Institute of Mental Health (NIMH)|