Status:
TERMINATED
Postpartum Depression: Transdermal Estradiol Versus Sertraline
Lead Sponsor:
Northwestern University
Conditions:
Postpartum Depression
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether estrogen patches are effective for the treatment of postpartum major depression, as compared to sertraline (Zoloft) and placebo.
Detailed Description
This study aims to advance our therapeutic armamentarium by evaluating the efficacy of estradiol (E2) therapy for Postpartum Major Depression (PPMD), which has received minimal research attention in A...
Eligibility Criteria
Inclusion
- Ages 18-45 years
- Had a baby within the last 3 months
- Experiencing depression or lasting sadness
Exclusion
- Current use of other therapies for depression, such as antidepressants, psychotherapy, bright light therapy, and herbal remedies such as Hypericum St. John's Wort
- DSM-IV diagnoses of bipolar 1 or 2 disorder or any psychotic episode; substance abuse within last 6 months
- Previous adverse reaction to sertraline or provera
- No pediatric care: No pediatrician with whom to coordinate breastfeeding and infant care
- Use of medications for medical disorders, except for treatment of hypothyroidism or inhalers for asthma or progestin-only contraceptives
- Heavy smoking (\>10 cigarettes per day) or intent to resume heavy smoking (unless willing to cut down)
- personal history of thromboembolic event, hypercoagulability, or first degree relatives with thromboembolic events.
- Current or past personal history of breast, uterine, or ovarian cancer.
- BRCA-positive mother
- Arterial vascular disease and/or heart disease: increased risk of stroke.
- Liver disease: increased risk of biliary stones, cholestatic jaundice and benign hepatic lesions with E2 treatment.
- Diabetes
- Pregnancy
- Infants born \<32 weeks of gestation
- Imminent suicidality and/or homicidality: in need of higher level of care than is provided in this study.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00744328
Start Date
August 1 2008
End Date
September 1 2013
Last Update
September 10 2019
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine; Asher Center for the Study and Treatment of Depressive Disorders
Chicago, Illinois, United States, 60611