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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: Clinical Trial study, sponsored by National Institute on Aging (NIA).

NCT01328613 is a clinical trial that was terminated before completion, run by National Institute on Aging (NIA). The registered enrollment target is 85 participants. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 85 participants
Start Date 2007-11-09
Est. Completion 2014-09-29
National Institute on Aging (NIA)

131 total trials

Why NCT01328613 stopped before completion

NCT01328613 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 85 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01328613 does not publish any study locations in the registry export this page uses.

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.

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Source: ClinicalTrials.gov NCT01328613, the US trial registry maintained by the National Library of Medicine. NCT01328613 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.