Screening Evaluation for Women With Postpartum Depression

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.

- INCLUSION CRITERIA:

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; 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.

EXCLUSION CRITERIA:

- 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.