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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 : October 23, 2014
Sponsor:
Information provided by (Responsible Party):
Katherine Wisner, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postpartum Depression
Interventions Drug: Transdermal Estradiol
Drug: Sertraline
Other: Placebo
Enrollment 85

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Estradiol Sertraline Placebo
Hide Arm/Group Description

Administered via skin patch ranging in dose from 50 to 200 mcg/day

Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day

Administered via capsules taken orally ranging in dose from 25 to 200mg/day

Sertraline: Sertraline dose will range from 50 - 200 mg/day

Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
Period Title: Overall Study
Started 26 30 29
Completed 19 22 21
Not Completed 7 8 8
Reason Not Completed
Lost to Follow-up             2             5             3
Withdrawal by Subject             5             3             4
Found ineligible after randomization             0             0             1
Arm/Group Title Estradiol Sertraline Placebo Total
Hide Arm/Group Description

Administered via skin patch ranging in dose from 50 to 200 mcg/day

Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day

Administered via capsules taken orally ranging in dose from 25 to 200mg/day

Sertraline: Sertraline dose will range from 50 - 200 mg/day

Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used. Total of all reporting groups
Overall Number of Baseline Participants 26 30 29 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 30 participants 29 participants 85 participants
26.2  (5.98) 26.2  (5.89) 27.4  (5.48) 26.6  (5.74)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 30 participants 29 participants 85 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
30
 100.0%
29
 100.0%
85
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 30 participants 29 participants 85 participants
Female
26
 100.0%
30
 100.0%
29
 100.0%
85
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 30 participants 29 participants 85 participants
American Indian or Alaska Native
0
   0.0%
1
   3.3%
0
   0.0%
1
   1.2%
Asian
0
   0.0%
0
   0.0%
3
  10.3%
3
   3.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   3.3%
0
   0.0%
1
   1.2%
Black or African American
10
  38.5%
9
  30.0%
4
  13.8%
23
  27.1%
White
14
  53.8%
19
  63.3%
21
  72.4%
54
  63.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   7.7%
0
   0.0%
1
   3.4%
3
   3.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 30 participants 29 participants 85 participants
26 30 29 85
SIGHADS29   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 26 participants 30 participants 29 participants 85 participants
23.3  (4.99) 23.3  (3.67) 25.1  (4.92) 23.9  (4.56)
[1]
Measure 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. A minimum SIGH-ADS29 score of 18 was required for enrollment.
1.Primary Outcome
Title To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyses presented are Last Observation Carried Forward. For women who completed the 8 week trial the percent change was measured from baseline to week 8. For non-completers, the percent change was measured from baseline to last observation.
Arm/Group Title Estradiol Sertraline Placebo
Hide Arm/Group Description:

Administered via skin patch ranging in dose from 50 to 200 mcg/day

Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day

Administered via capsules taken orally ranging in dose from 25 to 200mg/day

Sertraline: Sertraline dose will range from 50 - 200 mg/day

Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
Overall Number of Participants Analyzed 26 30 29
Mean (Standard Deviation)
Unit of Measure: percentage change in SIGH-ADS29 Score
-38  (33.7) -49  (24.1) -48  (29.8)
2.Secondary Outcome
Title Infant Development Among 6.5 Month Old Children of Mothers With PPMD, as Assessed by Bayley Scales of Infant Development
Hide Description [Not Specified]
Time Frame yearly
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Infant Serum Concentrations of Estradiol in 3 Treatment Arms
Hide Description [Not Specified]
Time Frame monthly
Outcome Measure Data Not Reported
4.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame yearly
Outcome Measure Data Not Reported
5.Secondary Outcome
Title To Explore the Relationship of Remission and Response to the Subjects’ Serum Levels of Estradiol.
Hide Description [Not Specified]
Time Frame Monthly
Outcome Measure Data Not Reported
Time Frame Weekly during the 8-week acute phase
Adverse Event Reporting Description If a patient develops a symptom score on the Mania Rating Scale of >10, she will receive an immediate consultation for a revised treatment regimen by non-blind medical monitor to keep primary study staff blind to pill/patch content. Occurrence of hypomania/mania will signal termination from the trial.
 
Arm/Group Title Estradiol Sertraline Placebo
Hide Arm/Group Description

Administered via skin patch ranging in dose from 50 to 200 mcg/day

Transdermal Estradiol: Estradiol patch ranging in dose from 50 to 200 mcg/day

Administered via capsules taken orally ranging in dose from 25 to 200mg/day

Sertraline: Sertraline dose will range from 50 - 200 mg/day

Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
All-Cause Mortality
Estradiol Sertraline Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Estradiol Sertraline Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/30 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Estradiol Sertraline Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   4/30 (13.33%)   1/29 (3.45%) 
Psychiatric disorders       
Treatment Emergent Manic Symptoms  1  0/26 (0.00%)  4/30 (13.33%)  1/29 (3.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Mania Rating Scale
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Research Study Coordinator
Organization: Northwestern University
Phone: 312-695-8441
Responsible Party: Katherine Wisner, Northwestern University
ClinicalTrials.gov Identifier: NCT00744328     History of Changes
Other Study ID Numbers: R01MH057102 ( U.S. NIH Grant/Contract )
First Submitted: August 28, 2008
First Posted: August 29, 2008
Results First Submitted: October 13, 2014
Results First Posted: October 23, 2014
Last Update Posted: October 23, 2014