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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: Clinical Trial Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
Why NCT00059228 stopped before completion
NCT00059228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT00059228 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00059228's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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