Postpartum Depression: Transdermal Estradiol Versus Sertraline

• Status: Terminated
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate; Sertraline

Criteria

Inclusion Criteria:

• Ages 18-45 years

• Had a baby within the last 3 months

• Experiencing depression or lasting sadness

Exclusion Criteria:

• 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.