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Screening Evaluation for Women with Postpartum Depression Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Screening Evaluation for Women with Postpartum Depression conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Screening Evaluation for Women with Postpartum Depression Clinical research trials and Screening Evaluation for Women with Postpartum Depression medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Screening Evaluation for Women with Postpartum Depression. Screening Evaluation for Women with Postpartum Depression Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Screening Evaluation for Women with Postpartum Depression clinical trial. Subjects typically recieve the finest healthcare available for their Screening Evaluation for Women with Postpartum Depression condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Screening Evaluation for Women with Postpartum Depression  Screening Evaluation for Women with Postpartum Depression
Screening Evaluation for Women with Postpartum Depression
For Condition: Postpartum Depression
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: Controversy exists regarding the relevance in changes in gonadal steroids for postpartum-onset depressions. In this protocol, we examine the possible role of gonadal steroids in these disorders in two ways. First, we identify groups of both depressed and asymptomatic women who are in the postpartum. Patients and controls are composed using baseline biological and phenomenological (e.g., life events, social support) measures in an attempt to identify potentially meaningful correlates of the occurrence of depression. Patient subjects also serve as participants in a companion protocol designed to identify the antidepressant efficacy of estradiol administration. Second, we identify pregnant women at risk for developing postpartum depression (PPD), 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 protocol to recruit subjects who are characterized with standard measures in this protocol and then offered participation in related studies.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry 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.
Total Enrollment: 650
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030138; 03-M-0138
Study Start Date: March 21, 2003
Record last reviewed: February 13, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056901
Other Postpartum Depression Studies:
1. The Effects of Hormones in Postpartum Mood Disorders
2. Clinical Trial of Estrogen for Postpartum Depression
3. Screening Evaluation for Women with Postpartum Depression
Related Studies:
Other Postpartum Depression Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Screening Evaluation for Women with Postpartum Depression
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