NCT00744328

Postpartum Depression: Transdermal Estradiol Versus Sertraline

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Postpartum Depression

Interventions

Type	Name	Description
DRUG	Transdermal Estradiol	Estradiol patch ranging in dose from 50 to 200 mcg/day
DRUG	Sertraline	Sertraline dose will range from 50 - 200 mg/day
OTHER	Placebo	Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.

Timeline

• Start date: 2008-08-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2008-08-29
• Last updated: 2019-09-10
• Results posted: 2014-10-23

Locations

1 site across 1 country: United States