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Postpartum Depression: Transdermal Estradiol Versus Sertraline (E2SERT)

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ClinicalTrials.gov Identifier: NCT00744328
Recruitment Status : Terminated (Recruitment Issues)
First Posted : August 29, 2008
Results First Posted : October 23, 2014
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Katherine Wisner, Northwestern University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Drug: Transdermal Estradiol Drug: Sertraline Other: Placebo Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postpartum Depression: Transdermal Estradiol Versus Sertraline
Study Start Date : August 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Infant Serum Concentrations of Estradiol in 3 Treatment Arms [ Time Frame: monthly ]
    As expected due to being stopped and therefore underpowered


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744328


Locations
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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
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Principal Investigator: Katherine L Wisner, MD, MS Northwestern University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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    
Other Study ID Numbers: R01MH057102 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2008    Key Record Dates
Results First Posted: October 23, 2014
Last Update Posted: September 10, 2019
Last Verified: August 2018
Keywords provided by Katherine Wisner, Northwestern University:
Postpartum depression
estradiol
Postpartum major depressive disorder
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Sertraline
Estradiol
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents