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NCT00001481 · ClinicalTrials.gov registry record · Phase 2
The Role of Hormones in Postpartum Mood Disorders
A Phase 2 study of Postpartum Depression, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
- 1
- Study location
NCT00001481: Completed Phase 2 study of Postpartum Depression, sponsored by National Institute of Mental Health (NIMH).
NCT00001481 is a Phase 2 study of Postpartum Depression that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 74 participants, below the 474-participant average among 47 other Postpartum Depression trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001481, a Phase 2 study of Postpartum Depression, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
- 1
- Study location
Study Summary
The present protocol is designed to create a "scaled-down" hormonal milieu of pregnancy and the puerperium in order to determine whether it is the abrupt withdrawal of gonadal steroids or the prolonged exposure to gonadal steroids that is associated with mood symptoms.
Primary Outcome
The Edinburgh Postnatal Depression Scale (EPDS) is a self-reported 10 item questionnaire to asses a participant's mood over the past week. Each question has four possible answers, scored from 0 to 3 with total score ranging from 0 to 30. Higher scores indicate more severe mood symptoms. EPDS was administered once every 2 weeks for the duration of the study. Analysis was calculated as the mean of scores for baseline (week 16) and weeks 18 and 20.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Progesterone
- DRUG Estradiol
- DRUG leuprolide acetate
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 1996-04-26 |
| Est. Completion | 2024-10-25 |
| Phase | Phase 2 |
What the finished NCT00001481 record still lists
NCT00001481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 474-participant average among 47 other Postpartum Depression trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Postpartum Depression appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00001481 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001481 about?
NCT00001481 is a clinical study titled "The Role of Hormones in Postpartum Mood Disorders". The present protocol is designed to create a "scaled-down" hormonal milieu of pregnancy and the puerperium in order to determine whether it is the abrupt withdrawal of gonadal steroids or the prolonged exposure to gonadal steroids that is associated with mood symptoms.
What is the current status of trial NCT00001481?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 1996-04-26. Estimated completion is 2024-10-25.
What conditions does trial NCT00001481 study?
This clinical trial studies the following conditions: Postpartum Depression.
What interventions are being tested in trial NCT00001481?
The interventions under investigation include: Placebo (OTHER), Progesterone (DRUG), Estradiol (DRUG), leuprolide acetate (DRUG).
Who is sponsoring clinical trial NCT00001481?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001481 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postpartum Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001481's enrollment target sits among peer trials
74 32nd of 47 higher than 16 of 47 other Postpartum Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Depression 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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