Clinical Validation of a Predictive Test for Postpartum Depression

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06831968
Status
Recruiting
Apply to this trial

Conditions

  • Postpartum Depression (PPD)
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Enlighten — DIAGNOSTIC_TEST
    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.

Study Details

The goal of this observational study is to develop a blood test that may be predictive of postpartum depression. This Blood test is investigational and not yet FDA approved. Participants will not receive the results of this blood test. 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.

Key Dates

Start date
Mar 20, 2025
Status verified
Nov 2025
Primary completion
Nov 30, 2026
Completion
Jul 31, 2028

Study Design

Enrollment
500 participants (estimated)

Primary Outcome Measure

Percentage of Participants with True/False Positive and Negative PPD Outcomes as Assessed by the Enlighten Device [ Time Frame: 6 months postpartum ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903-
Inova Health SystemFalls ChurchVirginia22042
Scott A Sullivan, MD
[email protected]
843-817-9046
Miranda Newell, MS
[email protected]
703-776-4600
Scott A Sullivan, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Virginia· Charlottesville, VAInova Health System· Falls Church, VA

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