Clinical Validation of a Predictive Test for Postpartum Depression
NCT ID: NCT06831968
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2025-03-20
2028-07-31
Brief Summary
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Up to 500 pregnant women will be recruited for the study from 2 sites. Participants must be age 18 or above with a singleton pregnancy and able to provide written consent in English.
The Objective of this Clinical Trial is to prospectively validate the Enlighten Device test by prospectively determining false/true positive and negative rates. Building off of this, an exploratory objective of this study is to examine clinical factors associated with false positive/negative rates.
This project will address the following Aim:
Aim 1: Prospective collection of true/false positive and negative PPD outcomes through 6 months postpartum.
Primary Hypothesis H1a: 80% or greater of pregnant women who develop PPD by 3 months after delivery will be determined to be Biomarker Positive by the Enlighten Device in T3.
Primary Hypothesis H1b: 10% or fewer of pregnant women who are determined to be Biomarker Negative by the Enlighten Device in T3 will develop PPD by 3 months after delivery.
Exploratory Aim 1: Investigation of clinical factors that may be associated with false positive and false negative rates, such as: medication use, stressful life events, and sociocultural context.
Participants will be screened during the second or third trimester and enrolled during the third trimester, before week 30 weeks of gestation. Participants may self- identify through study advertisements in participating clinics, social media outlets, and community outreach efforts. Enrolled participants will undergo blood collection during their 3rd trimester (\~27-30 weeks, a standard pregnancy-related blood collection timepoint) for completion of the Enlighten Device test, the blood-based epigenetic biomarker test. Participants will then be interviewed at 2 weeks, 6 weeks, 3 months, and 6 months postpartum for the development of depression symptoms. They'll also complete a multitude of other outcome measures at each of these visits.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Enlighten
The primary analysis will examine the performance of the Enlighten Device by evaluating biomarker status results ("elevated risk" or "low risk") at the third trimester against depression symptoms outcome data collected by the 3 months postpartum time point.
Eligibility Criteria
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Inclusion Criteria
* \<30 weeks' gestation, age 18 or above
* able to provide written consent in English
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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University of Virginia
OTHER
Responsible Party
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Jennifer L. Payne
Professor of Psychiatry and Neurobehavioral Sciences
Principal Investigators
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Jennifer L Payne, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Andrea Cubitt, PhD
Role: PRINCIPAL_INVESTIGATOR
Dionysus Digital Health, Inc.
Locations
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University of Virginia
Charlottesville, Virginia, United States
Inova Health System
Falls Church, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HT94252410544
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PR230933
Identifier Type: -
Identifier Source: org_study_id
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