Screening Evaluation for Women With Postpartum Depression
Postpartum Depression, Depression
About this trial
This is an observational trial for Postpartum Depression focused on measuring Puerperium, Pregnancy, Mood Disorders, Estradiol, Progesterone, Mood, Behavior, Cognition, Perimenopause, Menopause, Post Partum Depression, PPD, Healthy Volunteer, HV
Eligibility Criteria
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.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike