Postpartum Depression: Transdermal Estradiol Versus Sertraline (E2SERT)

This study has been terminated.
(Recruitment Issues)
Sponsor:
Information provided by (Responsible Party):
Katherine Wisner, Northwestern University
ClinicalTrials.gov Identifier:
NCT00744328
First received: August 28, 2008
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Postpartum Depression
Drug: Transdermal Estradiol
Drug: Sertraline
Other: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 85
Study Start Date: August 2008
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transdermal Estradiol
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
Drug: Transdermal Estradiol
Estradiol patch ranging in dose from 50 to 200 mcg/day
Other Names:
  • Vivelle dot
  • Climara
Other: Placebo
Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
Active Comparator: Sertraline
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
Drug: Sertraline
Sertraline dose will range from 50 - 200 mg/day
Other Name: Zoloft
Other: Placebo
Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
Placebo Comparator: Placebo
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.
Other: Placebo
Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744328

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine; Asher Center for the Study and Treatment of Depressive Disorders
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Katherine L Wisner, MD, MS Northwestern University
  More Information

Additional Information:
No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katherine Wisner, Norman and Helen Asher Professor of Psychiatry and Behavioral Sciences and Obstetrics and Gynecology; Director, Asher Center for the Study and Treatment of Depressive Disorders, Northwestern University
ClinicalTrials.gov Identifier: NCT00744328     History of Changes
Other Study ID Numbers: R01 MH057102
Study First Received: August 28, 2008
Results First Received: October 13, 2014
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Postpartum depression
estradiol
Postpartum major depressive disorder

Additional relevant MeSH terms:
Depression
Depression, Postpartum
Depressive Disorder
Puerperal Disorders
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pregnancy Complications
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Polyestradiol phosphate
Sertraline
Antidepressive Agents
Central Nervous System Agents
Contraceptive Agents
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Reproductive Control Agents
Serotonin Agents
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014