Postpartum Depression: Transdermal Estradiol Versus Sertraline (E2 SERT)
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.
Drug: Transdermal Estradiol
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Postpartum Depression: Transdermal Estradiol Versus Sertraline|
- To test the efficacy of estradiol for the treatment of postpartum depression [ Time Frame: bimonthly ] [ Designated as safety issue: No ]To test the efficacy of estradiol (E2) compared to placebo for the treatment of postpartum depression. Sertraline (Zoloft) will be included as an active comparator. We will test the hypothesis that Estradiol will be significantly more effective than placebo.
- Infant development among 6.5 month old children of mothers with PPMD, as assessed by Bayley Scales of Infant development [ Time Frame: yearly ] [ Designated as safety issue: No ]
- Infant serum concentrations of estradiol in 3 treatment arms [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
- To evaluate the durability of maternal response to Estradiol, Sertraline, and placebo in a continuation phase through the time the infant is assessed at 6.5 months of age. [ Time Frame: yearly ] [ Designated as safety issue: No ]
- To explore the relationship of remission and response to the subjects' serum levels of estradiol. [ Time Frame: Monthly ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Administered via skin patch ranging in dose from 50 to 200 mcg/day
Drug: Transdermal Estradiol
Estradiol patch ranging in dose from 50 to 200 mcg/day
Active Comparator: Sertraline
Administered via capsules taken orally ranging in dose from 25 to 200mg/day
Sertraline dose will range from 50 - 200 mg/day
Other Name: Zoloft
|Placebo Comparator: Placebo||
Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744328
|United States, Illinois|
|Northwestern University Feinberg School of Medicine; Asher Center for the Study and Treatment of Depressive Disorders|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Katherine L Wisner, MD, MS||Northwestern University|