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Trial record 28 of 49 for:    Postpartum Depression AND PPD | "Depression" AND "Depression"

Clinical Trial of Estrogen for Postpartum Depression

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ClinicalTrials.gov Identifier: NCT00059228
Recruitment Status : Terminated
First Posted : April 22, 2003
Results First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Postpartum Depression
Depression
Interventions Drug: 17beta Estradiol
Drug: Placebos
Enrollment 12

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Estradiol Placebo
Hide Arm/Group Description Estradiol transdermal patch 100mcg Placebo transdermal patch
Period Title: Overall Study
Started 6 6
Completed 6 5
Not Completed 0 1
Arm/Group Title Estradiol Placebo Total
Hide Arm/Group Description Estradiol transdermal patch 100mcg Placebo transdermal patch Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
6
 100.0%
6
 100.0%
12
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Hispanic or Latino
1
  16.7%
1
  16.7%
2
  16.7%
Not Hispanic or Latino
5
  83.3%
5
  83.3%
10
  83.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  16.7%
0
   0.0%
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  33.3%
2
  33.3%
4
  33.3%
White
2
  33.3%
3
  50.0%
5
  41.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  16.7%
1
  16.7%
2
  16.7%
1.Primary Outcome
Title Beck Depression Inventory
Hide Description The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Higher total scores indicate more severe depressive symptoms. The range of scores vary from 0 to 63 (highest possible total) for the whole test. A score of 0 – 10 indicates minimal depression, while a score of over 40 indicates extreme depression. No subscales were used for this outcome.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis included only those subjects who had taken Estradiol and Placebo
Arm/Group Title Estradiol Placebo
Hide Arm/Group Description:
Estradiol transdermal patch 100mcg
Placebo transdermal patch
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
15.84  (3.91) 5.3  (3.19)
2.Primary Outcome
Title Beck Depression Inventory
Hide Description The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Higher total scores indicate more severe depressive symptoms. The range of scores vary from 0 to 63 (highest possible total) for the whole test. A score of 0 – 10 indicates minimal depression, while a score of over 40 indicates extreme depression. No subscales were used for this outcome.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis included only those subjects who had taken Estradiol and Placebo
Arm/Group Title Estradiol Placebo
Hide Arm/Group Description:
Estradiol transdermal patch 100mcg
Placebo transdermal patch
Overall Number of Participants Analyzed 6 6
Mean (Standard Error)
Unit of Measure: units on a scale
26  (2.62) 27.67  (3.72)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Estradiol Placebo
Hide Arm/Group Description Estradiol transdermal patch 100mcg Placebo transdermal patch
All-Cause Mortality
Estradiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Estradiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Estradiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   1/6 (16.67%) 
Gastrointestinal disorders     
Nausea   0/6 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Schmidt, Peter
Organization: National Institute of Mental Health
Phone: +1 301 496 6120
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT00059228     History of Changes
Other Study ID Numbers: 030161
03-M-0161
First Submitted: April 22, 2003
First Posted: April 22, 2003
Results First Submitted: April 10, 2018
Results First Posted: June 13, 2018
Last Update Posted: June 13, 2018