Trial Outcomes & Findings for Clinical Trial of Estrogen for Postpartum Depression (NCT NCT00059228)
NCT ID: NCT00059228
Last Updated: 2018-06-13
Results Overview
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.
TERMINATED
PHASE2
12 participants
6 weeks
2018-06-13
Participant Flow
Participant milestones
| Measure |
Estradiol
Estradiol transdermal patch 100mcg
|
Placebo
Placebo transdermal patch
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of Estrogen for Postpartum Depression
Baseline characteristics by cohort
| Measure |
Estradiol
n=6 Participants
Estradiol transdermal patch 100mcg
|
Placebo
n=6 Participants
Placebo transdermal patch
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The analysis included only those subjects who had taken Estradiol and Placebo
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.
Outcome measures
| Measure |
Estradiol
n=6 Participants
Estradiol transdermal patch 100mcg
|
Placebo
n=6 Participants
Placebo transdermal patch
|
|---|---|---|
|
Beck Depression Inventory
|
15.84 Units on a scale
Standard Error 3.91
|
5.3 Units on a scale
Standard Error 3.19
|
PRIMARY outcome
Timeframe: BaselinePopulation: The analysis included only those subjects who had taken Estradiol and Placebo
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.
Outcome measures
| Measure |
Estradiol
n=6 Participants
Estradiol transdermal patch 100mcg
|
Placebo
n=6 Participants
Placebo transdermal patch
|
|---|---|---|
|
Beck Depression Inventory
|
26 units on a scale
Standard Error 2.62
|
27.67 units on a scale
Standard Error 3.72
|
Adverse Events
Estradiol
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Estradiol
n=6 participants at risk
Estradiol transdermal patch 100mcg
|
Placebo
n=6 participants at risk
Placebo transdermal patch
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
16.7%
1/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place