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Tracking Information | |||||||||
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First Received Date † | March 26, 2003 | ||||||||
Last Updated Date | February 28, 2009 | ||||||||
Start Date † | March 2003 | ||||||||
Current Primary Outcome Measures † | |||||||||
Original Primary Outcome Measures † | |||||||||
Change History | Complete list of historical versions of study NCT00056901 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | Screening Evaluation for Women With Postpartum Depression | ||||||||
Official Title † | A Screening Protocol to Evaluate Women With Postpartum-Related Mood and Behavioral Disorders | ||||||||
Brief Summary | 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. ... |
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Detailed Description | Controversy exists regarding the relevance of changes in gonadal steroids for postpartum-onset depressions. The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols that examine the role of gonadal steroids in postpartum-onset depressions (PPD) and for the collection of natural history data. Women in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; blood and urine laboratory evaluation; and a request for medical records. The data collected may also be linked with data from other PPD protocols (e.g., DNA, psychophysiology tests, treatment studies, etc.) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of women with PPD. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The second purpose of this protocol is to permit the identification of pregnant women who are at risk for developing postpartum depression (PPD), and who are followed longitudinally through the postpartum in an effort to confirm the association of depression onset with change in reproductive endocrine function. This protocol, then, serves as a screening and evaluation protocol to recruit subjects who are characterized with standard measures in this protocol and then offered participation in related studies. |
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Study Phase | |||||||||
Study Type † | Observational | ||||||||
Study Design † | |||||||||
Condition † |
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Intervention † | |||||||||
Study Arms / Comparison Groups | |||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 650 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † |
A/Cross-sectional Screening: The postpartum subjects of this protocol will be women who meet the following inclusion criteria:
EXCLUSION CRITERIA:
B/Longitudinal Screening: INCLUSION CRITERIA FOR THE AT RISK PREGNANT WOMEN:
C/Genetic Studies: INCLUSION CRITERIA: Unaffected family members of women with PPD will be admitted for genetic studies only. First degree relatives of women with confirmed PPD, who do not have PPD as defined in this protocol. |
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Gender | Female | ||||||||
Ages | 20 Years to 45 Years | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00056901 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | 03-M-0138 | ||||||||
Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
Collaborators †† | |||||||||
Investigators † | |||||||||
Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
Verification Date | December 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |