Clinical Trial of Estrogen for Postpartum Depression
Status:
Terminated
Trial end date:
2016-11-15
Target enrollment:
Participant gender:
Summary
This study evaluates the efficacy of estrogen treatment in women with postpartum depression
(PPD).
PPD causes significant distress to a large number of women; the demand for effective
therapies to treat PPD is considerable. Estradiol therapy has a prophylactic effect in women
at high risk for developing PPD. The prevention of a decline in estradiol levels may prevent
the onset of PPD. Studies also suggest that estradiol has antidepressant effects in women and
may provide a safe and effective alternative to traditional antidepressants in women with
PPD.
Participants will be screened with a medical history, physical examination, blood and urine
tests, psychological tests, genetic studies, and self-rating scales and questionnaires. Upon
study entry, women will be randomly assigned to wear skin patches containing either estradiol
or placebo (a patch with no active ingredient) for 6 weeks. Women who receive estradiol and
do not menstruate during the last week of the study will receive progesterone for 7 days to
initiate menstruation. Women who receive placebo and do not menstruate during the last week
of the study will continue to receive placebo at the end of the study. Every week,
participants will have blood taken and will be asked to complete symptom self-rating scales.
A urine sample and blood samples will be collected at different time points through out of
the study. Participants who receive placebo and those whose symptoms do not improve with
estradiol therapy will be offered treatment with standard antidepressant medications for 8
weeks at the end of the study.