Postpartum Depression: Transdermal Estradiol Versus Sertraline

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Postpartum Depression

In brief

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.

Key facts

Study ID

NCT00744328

Run by

Northwestern University

People needed

85

Starts

2008-08-01

Expected to finish

2013-09-01

Last updated by the study team

2019-09-10

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18-45 years
• Had a baby within the last 3 months
• Experiencing depression or lasting sadness

You may not qualify if…

• 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.

Where it is running

• Northwestern University Feinberg School of Medicine; Asher Center for the Study and Treatment of Depressive Disorders — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.