Screening Evaluation for Women With Postpartum Depression

Stopped early

Conditions studied: Postpartum Depression, Depression

In brief

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. ...

Key facts

Study ID: NCT00056901
Run by: National Institute of Mental Health (NIMH)
People needed: 68
Starts: 2003-03-25
Expected to finish: 2017-12-24
Last updated by the study team: 2018-02-14

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Unaffected family members of women with PPD will be admitted for genetic studies only who are first degree relatives of women with confirmed PPD, and who do not have PPD as defined in this protocol.

You may not qualify if…

Current antidepressant therapy
Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder);
Current alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups).
This protocol is a screening protocol for an estradiol treatment study (03-M-0161) for which the exclusion criteria include the current use of antidepressant medications. However, antidepressants will not be withheld from subjects who need or want them. Immediately after screening subjects will either be enrolled in the estrogen treatment study or in traditional therapy until care can be transitioned to the community. There are few exclusion criteria for the evaluation component of this protocol; however, all women will undergo a structured diagnostic interview Those women who will be asked to participate in the companion protocol evaluating the efficacy of estradiol administration in PPD will meet either research diagnostic criteria for minor depression with at least three core symptoms (SADS-L (90) or major depression (SCID-IV) (91) of not greater than moderate severity on the Global Assessment of Functioning Scale (GAF) (91)) and will not meet DSM-IV criteria # 9 (suicide) or require immediate treatment. Subjects meeting major depression with greater than moderate severity may participate in the evaluation phase of this study but will be offered a referral to an outside facility for standard antidepressant treatment (i.e., they are not candidates for participation in the IRB approved treatment protocol).
LONGITUDINAL SCREENING:
INCLUSION CRITERIA FOR THE AT RISK PREGNANT WOMEN:
Pregnant;
Absence of current mood or behavioral disturbance as determined by a structured diagnostic interview;
Past history of postpartum depression;
In good medical health,
Medication free.
GENETIC STUDIES:
INCLUSION CRITERIA:
Unaffected family members of women with PPD will be admitted for genetic studies only who are first degree relatives of women with confirmed PPD, and who do not have PPD as defined in this protocol.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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