Clinical Trial: Postpartum Depression: Transdermal Estradiol Versus Sertraline

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Postpartum Depression: Transdermal Estradiol Versus Sertraline

Brief 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 Summary: 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.
Sponsor: Northwestern University

Current Primary Outcome: To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29 [ Time Frame: Week 8 ]

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.


Original Primary Outcome:

  • Percent of subjects, in each treatment arm, with remission of major depressive episode [ Time Frame: yearly ]
  • Time to remission of major depressive episode [ Time Frame: yearly ]
  • Number of venous thromboembolic events in the 3 treatment arms [ Time Frame: monthly ]
  • Endometrial hyperplasia cases in each treatment arm [ Time Frame: monthly ]
  • Incident breast CA cases in the 3 treatment arms [ Time Frame: monthly ]
  • Irregular vaginal bleeding in the 3 treatment arms [ Time Frame: monthly ]
  • Undesired breastfeeding discontinuation in the 3 treatment arms [ Time Frame: monthly ]


Current Secondary Outcome:

  • Infant Development Among 6.5 Month Old Children of Mothers With PPMD, as Assessed by Bayley Scales of Infant Development [ Time Frame: yearly ]
  • Infant Serum Concentrations of Estradiol in 3 Treatment Arms [ Time Frame: monthly ]
  • 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 ]
  • To Explore the Relationship of Remission and Response to the Subjects' Serum Levels of Estradiol. [ Time Frame: Monthly ]


Original Secondary Outcome:

  • Infant Development Among 6.5 Month Old Children of Mothers With PPMD, as Assessed by Bayley Scales of Infant Development [ Time Frame: yearly ]
  • Infant Serum Concentrations of Estradiol in 3 Treatment Arms [ Time Frame: monthly ]


Information By: Northwestern University

Dates:
Date Received: August 28, 2008
Date Started: August 2008
Date Completion:
Last Updated: October 20, 2014
Last Verified: October 2014