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Screening Evaluation for Women With Postpartum Depression
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), January 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00056901

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.


Postpartum Depression

MedlinePlus related topics: Depression Postpartum Depression
Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Progesterone
U.S. FDA Resources
Study Type: Observational
Official Title: A Screening Protocol to Evaluate Women With Postpartum-Related Mood and Behavioral Disorders

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 650
Study Start Date: March 2003
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.


Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

A/Cross-sectional Screening: The postpartum subjects of this protocol will be women who meet the following inclusion criteria:

  • History 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;
  • The onset of mood symptoms occurred within three months of delivery;
  • Age 20-45;
  • History of normal delivery (vaginal or caesarean) within last six months;
  • No prior estrogen replacement therapy for treatment of postpartum physical or emotional symptoms within the last six months;
  • In good medical health.
  • Subjects must be competent to comprehend the purpose of the screening process and to provide written informed consent and be willing to participate in NIMH IRB approved research protocols.
  • 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.


  • 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).
  • There are few exclusion criteria for the evaluation component of this protocol; however, all women will undergo a structured diagnostic interview (see Clinical Assessment section below). 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 (79) or major depression (SCID-IV) (80) of not greater than moderate severity on the Global Assessment of Functioning Scale (GAF) (80)) 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).

B/Longitudinal Screening:


  • 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.

C/Genetic Studies:


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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056901

Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Study ID Numbers: 030138, 03-M-0138
Study First Received: March 26, 2003
Last Updated: July 18, 2008
ClinicalTrials.gov Identifier: NCT00056901  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Mood Disorders
Post Partum Depression
Healthy Volunteer

Study placed in the following topic categories:
Pregnancy Complications
Estradiol valerate
Estradiol 17 beta-cypionate
Depressive Disorder
Behavioral Symptoms
Depression, Postpartum
Puerperal Disorders
Mental Disorders
Estradiol 3-benzoate
Mood Disorders
Polyestradiol phosphate

ClinicalTrials.gov processed this record on January 30, 2009