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Clinical Validation of a Predictive Test for Postpartum Depression
NCT06831968 · View on ClinicalTrials.gov ↗
Study Summary
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,
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Enlighten
Study Locations (2)
Virginia
- University of Virginia — Charlottesville
- Inova Health System — Falls Church
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-03-20 |
| Est. Completion | 2028-07-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06831968
The ClinicalTrials.gov registry entry for NCT06831968 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 392 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention — of which Enlighten is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06831968 reports 2 study locations spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06831968 about?
NCT06831968 is a clinical study titled "Clinical Validation of a Predictive Test for Postpartum Depression". 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...
What is the current status of trial NCT06831968?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2025-03-20. Estimated completion is 2028-07-31.
What conditions does trial NCT06831968 study?
This clinical trial studies the following conditions: Pregnancy, Postpartum Depression (PPD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06831968?
The interventions under investigation include: Enlighten (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06831968?
This trial is sponsored by University of Virginia, which has 392 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06831968 being conducted?
This trial has 2 study locations across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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