Back to resultsPostpartum Depression: Transdermal Estradiol Versus Sertraline (E2SERT)
Primary Purpose
Postpartum Depression
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Transdermal Estradiol
Sertraline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Depression focused on measuring Postpartum depression, estradiol, Postpartum major depressive disorder
Eligibility 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.
Sites / Locations
- Northwestern University Feinberg School of Medicine; Asher Center for the Study and Treatment of Depressive Disorders
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Transdermal Estradiol
Sertraline
Placebo
Arm Description
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
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
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.
Outcomes
Primary Outcome Measures
To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29
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 Serum Concentrations of Estradiol in 3 Treatment Arms
As expected due to being stopped and therefore underpowered
Full Information
NCT ID
NCT00744328
First Posted
August 28, 2008
Last Updated
August 19, 2019
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT00744328
Brief Title
Postpartum Depression: Transdermal Estradiol Versus Sertraline
Acronym
E2SERT
Official Title
Postpartum Depression: Transdermal Estradiol Versus Sertraline
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Recruitment Issues
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Postpartum depression, estradiol, Postpartum major depressive disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transdermal Estradiol
Arm Type
Experimental
Arm Description
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
Arm Title
Sertraline
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Transdermal Estradiol
Other Intervention Name(s)
Vivelle dot, Climara
Intervention Description
Estradiol patch ranging in dose from 50 to 200 mcg/day
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
Sertraline dose will range from 50 - 200 mg/day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
Primary Outcome Measure Information:
Title
To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29
Description
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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Infant Serum Concentrations of Estradiol in 3 Treatment Arms
Description
As expected due to being stopped and therefore underpowered
Time Frame
monthly
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L Wisner, MD, MS
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine; Asher Center for the Study and Treatment of Depressive Disorders
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22283499
Citation
Prairie BA, Wisniewski SR, Luther JF, Sit D, Wisner KL. Postpartum lipid levels in women with major depression. J Womens Health (Larchmt). 2012 May;21(5):534-8. doi: 10.1089/jwh.2011.3256. Epub 2012 Jan 27.
Results Reference
derived
Links:
URL
http://psychiatry.northwestern.edu
Description
Northwestern Psychiatry Homepage
Learn more about this trial
Postpartum Depression: Transdermal Estradiol Versus Sertraline
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