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NCT00059228 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of Estrogen for Postpartum Depression
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00059228 is a Phase 2 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 12 participants.
The verdict
NCT00059228, a Phase 2 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebos
- DRUG 17beta Estradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2003-04-17 |
| Est. Completion | 2016-11-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00059228
The ClinicalTrials.gov registry entry for NCT00059228 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT00059228 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00059228 about?
NCT00059228 is a clinical study titled "Clinical Trial of Estrogen for Postpartum Depression". 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 devel...
What is the current status of trial NCT00059228?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2003-04-17. Estimated completion is 2016-11-15.
What interventions are being tested in trial NCT00059228?
The interventions under investigation include: Placebos (DRUG), 17beta Estradiol (DRUG).
Who is sponsoring clinical trial NCT00059228?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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