Postpartum Depression: Transdermal Estradiol Versus Sertraline (E2SERT)

Northwestern University

Status and phase: Terminated; Phase 4

Conditions: Postpartum Depression

Treatments: Other: Placebo; Drug: Sertraline; Drug: Transdermal Estradiol

Study type: Interventional

Funder types: Other

Identifiers

NCT00744328

R01MH057102

Details and patient eligibility

About

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.

Full 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 America. The design of the proposed study is an 8 week randomized double-blind clinical trial of SERT vs. E2 vs. Placebo. Responders enter a continuation phase with the blind intact through 6.5 months postpartum. The primary aims of this investigation are to: 1) Test the efficacy of E2 compared to placebo for the treatment of PPMD. Sertraline will be included as an active comparator. We have powered the study to test for differences among the three groups and also test for differences between the E2 and placebo group. We will test the hypothesis that E2 will be significantly more effective than placebo and that SERT will be significantly more effective than placebo. 2) Evaluate developmental outcomes in infants exposed to the disorder, PPMD, and the medications (SERT, exogenous E2 or Placebo) which may be transmitted to the infants through breastfeeding. All infants in this study will have exposure to mothers with depression. We will assess maternal depression, mother-infant serum SERT and E2 levels and relate them to mother-infant interactional quality and infant developmental outcomes on the Bayley Scales of Infant Development. These data will enhance the sophistication of risk-benefit analyses for pharmacotherapy during lactation.

Enrollment: 85 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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85 participants in 3 patient groups, including a placebo group

Transdermal Estradiol

Experimental group

Description:

Women wear a skin patch that is changed weekly and take opaque capsules by mouth daily. The capsules for women in this arm do not contain any active ingredients. The skin patch contains transdermal estradiol ranging in dose from 50 to 200 mcg/day

Treatment:

Drug: Transdermal Estradiol

Other: Placebo

Sertraline

Active Comparator group

Description:

Women wear a skin patch that is changed weekly and take opaque capsules by mouth daily. The skin patch contains no active ingredients, though packaging is designed to match active patches. The capsules contain sertraline ranging in dose from 25 to 200mg/day

Treatment:

Other: Placebo

Drug: Sertraline

Placebo

Placebo Comparator group

Description:

Women wear a skin patch that is changed weekly and take opaque capsules by mouth daily. The capsules for women in this arm do not contain any active ingredients. The skin patch contains no active ingredients, though packaging is designed to match active patches.

Treatment:

Other: Placebo