Screening Evaluation for Women With Postpartum Depression

NCT00056901 | Terminated

• 2 other identifiers: 03013803-M-0138
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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. ...

Conditions

Postpartum Depression; Depression

Keywords

Puerperium; Pregnancy; Mood Disorders; Estradiol; Progesterone; Mood; Behavior; Cognition; Perimenopause; Menopause; Post Partum Depression; PPD; Healthy Volunteer; HV

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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; The selection of the lower limit of this age window is intended to reduce the potential confound that the psychosocial stress of a teenage pregnancy could complicate the relationship between postpartum hormonal events and mood. The upper age limit was selected since pregnancy and childbirth in a woman over this age range could lead to spontaneous menopause and, therefore, our ability to discern the effects of estrogen therapy on mood could be complicated by estrogen s effects on menopausal symptoms.
• 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.

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).
• 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.
• GENETIC STUDIES:
• 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Kumar R, Robson KM. A prospective study of emotional disorders in childbearing women. Br J Psychiatry. 1984 Jan;144:35-47. doi: 10.1192/bjp.144.1.35.

  PMID: 6692075 BACKGROUND

• Cox JL, Murray D, Chapman G. A controlled study of the onset, duration and prevalence of postnatal depression. Br J Psychiatry. 1993 Jul;163:27-31. doi: 10.1192/bjp.163.1.27.

  PMID: 8353695 BACKGROUND

• O'Hara MW, Schlechte JA, Lewis DA, Varner MW. Controlled prospective study of postpartum mood disorders: psychological, environmental, and hormonal variables. J Abnorm Psychol. 1991 Feb;100(1):63-73. doi: 10.1037//0021-843x.100.1.63.

  PMID: 2005273 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum; Depression; Mood Disorders; Behavior

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mental Disorders; Behavioral Symptoms

Study Officials

• Peter J Schmidt, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2003
• First Posted: March 26, 2003
• Study Start: March 25, 2003
• Study Completion: December 24, 2017
• Last Updated: February 14, 2018

Record last verified: 2017-12-24

Locations

US (1)