Postpartum Depression: Transdermal Estradiol Versus Sertraline (E2 SERT)

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: February 14, 2014
Last verified: February 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 [ 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.


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: Estradiol
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
Other Names:
  • Vivelle dot
  • Climara
Active Comparator: Sertraline
Administered via capsules taken orally ranging in dose from 25 to 200mg/day
Drug: Sertraline
Sertraline dose will range from 50 - 200 mg/day
Other Name: Zoloft
Placebo Comparator: Placebo 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
Last Updated: February 14, 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, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Sertraline
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014