ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 48 of 331 for:    SERTRALINE

Postpartum Depression: Transdermal Estradiol Versus Sertraline (E2SERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Estradiol

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

Sertraline

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: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.

Participant Flow:   Overall Study
    Estradiol   Sertraline   Placebo
STARTED   26   30   29 
COMPLETED   19   22   21 
NOT COMPLETED   7   8   8 
Lost to Follow-up                2                5                3 
Withdrawal by Subject                5                3                4 
Found ineligible after randomization                0                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Estradiol

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

Sertraline

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: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
Total Total of all reporting groups

Baseline Measures
   Estradiol   Sertraline   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   30   29   85 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.2  (5.98)   26.2  (5.89)   27.4  (5.48)   26.6  (5.74) 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   26   30   29   85 
>=65 years   0   0   0   0 
Gender 
[Units: Participants]
       
Female   26   30   29   85 
Male   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   1   0   1 
Asian   0   0   3   3 
Native Hawaiian or Other Pacific Islander   0   1   0   1 
Black or African American   10   9   4   23 
White   14   19   21   54 
More than one race   0   0   0   0 
Unknown or Not Reported   2   0   1   3 
Region of Enrollment 
[Units: Participants]
       
United States   26   30   29   85 
SIGHADS29 [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 23.3  (4.99)   23.3  (3.67)   25.1  (4.92)   23.9  (4.56) 
[1] 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.


  Outcome Measures

1.  Primary:   To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29   [ Time Frame: Week 8 ]

2.  Secondary:   Infant Development Among 6.5 Month Old Children of Mothers With PPMD, as Assessed by Bayley Scales of Infant Development   [ Time Frame: yearly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Infant Serum Concentrations of Estradiol in 3 Treatment Arms   [ Time Frame: monthly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   To Explore the Relationship of Remission and Response to the Subjects’ Serum Levels of Estradiol.   [ Time Frame: Monthly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: emily.pinheiro@northwestern.edu


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

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