Postpartum Depression: Transdermal Estradiol Versus Sertraline

Phase 4TerminatedNCT00744328

Northwestern University85 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postpartum Depression

Interventions

Transdermal EstradiolDRUG

Estradiol patch ranging in dose from 50 to 200 mcg/day

SertralineDRUG

Sertraline dose will range from 50 - 200 mg/day

PlaceboOTHER

Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Northwestern University Feinberg School of Medicine; Asher Center for the Study and Treatment of Depressive Disorders

Chicago, Illinois, United States

Outcomes

Primary Outcomes

To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29

Depression was assessed with the Structured Interview Guide for the Hamilton Depression Rating Scale - Atypical Depression Symptoms Version (SIGH-ADS29). The scale incorporates the 17 and 21-item Hamilton Rating Scales for Depression (HRSD) as well as 8 atypical symptoms of depression. Scores range from 0 to 90, where a higher score corresponds to a higher level of depressive symptomatology.

Time frame: Week 8

Secondary Outcomes

Infant Serum Concentrations of Estradiol in 3 Treatment Arms

As expected due to being stopped and therefore underpowered

Time frame: monthly

Data from ClinicalTrials.gov

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