Trial Outcomes & Findings for Postpartum Depression: Transdermal Estradiol Versus Sertraline (NCT NCT00744328)
NCT ID: NCT00744328
Last Updated: 2019-09-10
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
85 participants
Primary outcome timeframe
Week 8
Results posted on
2019-09-10
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
30
|
29
|
|
Overall Study
COMPLETED
|
19
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
8
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
4
|
|
Overall Study
Found ineligible after randomization
|
0
|
0
|
1
|
Baseline Characteristics
Postpartum Depression: Transdermal Estradiol Versus Sertraline
Baseline characteristics by cohort
| Measure |
Estradiol
n=26 Participants
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
n=30 Participants
Administered via capsules taken orally ranging in dose from 25 to 200mg/day
Sertraline: Sertraline dose will range from 50 - 200 mg/day
|
Placebo
n=29 Participants
Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.2 years
STANDARD_DEVIATION 5.98 • n=5 Participants
|
26.2 years
STANDARD_DEVIATION 5.89 • n=7 Participants
|
27.4 years
STANDARD_DEVIATION 5.48 • n=5 Participants
|
26.6 years
STANDARD_DEVIATION 5.74 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
30 participants
n=7 Participants
|
29 participants
n=5 Participants
|
85 participants
n=4 Participants
|
|
SIGHADS29
|
23.3 Scores on a scale
STANDARD_DEVIATION 4.99 • n=5 Participants
|
23.3 Scores on a scale
STANDARD_DEVIATION 3.67 • n=7 Participants
|
25.1 Scores on a scale
STANDARD_DEVIATION 4.92 • n=5 Participants
|
23.9 Scores on a scale
STANDARD_DEVIATION 4.56 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: 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.
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.
Outcome measures
| Measure |
Estradiol
n=26 Participants
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
n=30 Participants
Administered via capsules taken orally ranging in dose from 25 to 200mg/day
Sertraline: Sertraline dose will range from 50 - 200 mg/day
|
Placebo
n=29 Participants
Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
|
|---|---|---|---|
|
To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29
|
-38 percentage change in SIGH-ADS29 Score
Standard Deviation 33.7
|
-49 percentage change in SIGH-ADS29 Score
Standard Deviation 24.1
|
-48 percentage change in SIGH-ADS29 Score
Standard Deviation 29.8
|
SECONDARY outcome
Timeframe: monthlyAs expected due to being stopped and therefore underpowered
Outcome measures
| Measure |
Estradiol
n=6 Participants
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
n=6 Participants
Administered via capsules taken orally ranging in dose from 25 to 200mg/day
Sertraline: Sertraline dose will range from 50 - 200 mg/day
|
Placebo
n=7 Participants
Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
|
|---|---|---|---|
|
Infant Serum Concentrations of Estradiol in 3 Treatment Arms
|
2.45 pg/mL
Standard Deviation 3.80
|
2.1 pg/mL
Standard Deviation 3.36
|
5.59 pg/mL
Standard Deviation 7.79
|
Adverse Events
Estradiol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sertraline
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Estradiol
n=26 participants at risk
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
n=30 participants at risk
Administered via capsules taken orally ranging in dose from 25 to 200mg/day
Sertraline: Sertraline dose will range from 50 - 200 mg/day
|
Placebo
n=29 participants at risk
Placebo: Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
|
|---|---|---|---|
|
Psychiatric disorders
Treatment Emergent Manic Symptoms
|
0.00%
0/26 • Weekly during the 8-week acute phase
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.
|
13.3%
4/30 • Weekly during the 8-week acute phase
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.
|
3.4%
1/29 • Weekly during the 8-week acute phase
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place