Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01328613 · ClinicalTrials.gov registry record
A Prospective Study of Postpartum Depression in Women With Major Depression
A clinical trial, sponsored by National Institute on Aging (NIA).
- Terminated
- Registry status
- 85
- Enrollment target
NCT01328613 is a clinical trial that was terminated before completion, run by National Institute on Aging (NIA). The registered enrollment target is 85 participants.
The verdict
NCT01328613 was terminated before completion, sponsored by National Institute on Aging (NIA).
- TERMINATED
- Registry status
- 85 participants
- Enrollment target
Study Summary
Background: \- Postpartum depression (PPD) is a serious syndrome that resembles a major depressive episode and occurs in 10% to 20% of all mothers in the year following delivery. Women with histories of major depressive disorder (MDD) are at an increased risk for PPD and recurrent PPD with subsequent pregnancies. One possible genetic vulnerability to depression and PPD in particular is the BDNF gene. BDNF is a protein that affects the growth and development of brain cells, including those that help to regulate mood. BDNF levels have been shown to be significantly lower in individuals with depression, including women. Researchers are interested in studying BDNF levels and hormones such as estrogen in pregnant women who have MDD and are at risk for developing PPD. Objectives: \- To study connections between the BDNF protein and hormonal levels in pregnant women who are at risk for developing postpartum depression. Eligibility: \- Women who are currently pregnant and have a history of major depressive disorder, and either are taking a selective serotonin reuptake inhibitor (SSRI) or are not taking an antidepressant. Design: * This study involves six visits over the course of 12 months, during the first, second, and third trimesters (if possible) as well as 1 week, 1 month, and 3 months postpartum. Women will be allowed to participate at any point during pregnancy, but researchers are most interested in recruiting women who are in the first trimester. * Participants will be screened with a physical examination and medical history, blood samples, and questionnaires about their history of depressive episodes. * At each visit, participants will complete a number of questionnaires on depression symptoms, such as sleep disturbance and stress levels. Participants will also provide blood samples for hormone and other testing. * Participants who become depressed during the study will be referred to a treating psychiatrist or other professional for appropriate care and tr
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2007-11-09 |
| Est. Completion | 2014-09-29 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01328613
The ClinicalTrials.gov registry entry for NCT01328613 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Aging (NIA), which has 131 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01328613 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01328613 about?
NCT01328613 is a clinical study titled "A Prospective Study of Postpartum Depression in Women With Major Depression". Background: \- Postpartum depression (PPD) is a serious syndrome that resembles a major depressive episode and occurs in 10% to 20% of all mothers in the year following delivery. Women with histories of major depressive disorder (MDD) are at an increased risk for PPD and recurrent PPD with subseque...
What is the current status of trial NCT01328613?
This trial is currently terminated. The enrollment target is 85 participants. The study started on 2007-11-09. Estimated completion is 2014-09-29.
Who is sponsoring clinical trial NCT01328613?
This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.