A Study of a Test for Postpartum Depression at Home
Public ClinicalTrials.gov record NCT07186309. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective Validation of the Enlighten Device in Predicting Postpartum Depression Using At-Home Sample Collection in Both Blood and Saliva
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will seek to prospectively validate the Enlighten Device for prediction of PPD by examining true/false positive and negative rates of the test using PPD outcomes collected through 3 months postpartum; compare the accuracy of biomarkers and algorithm in determining risk for PPD in blood compared to saliva; determine the utility of a week 6 sample collection in identifying women who are currently experiencing PPD thus bringing them to clinical attention. Our population will consist of pregnant women aged 18 and older up to 33 weeks of gestation. This research involves two groups of potentially vulnerable subjects: pregnant women and their infants. Because this is a study of postpartum depression (PPD), inclusion of these two vulnerable subjects is required. The study will enroll 1000 pregnant non-adolescent women of childbearing age who meet eligibility criteria. This project will address the following Aims: Specific Aim 1: Prospective collection of true/false positive and negative PPD outcomes through 3 months postpartum. Primary Hypothesis H1a: 80% or greater of pregnant women who develop postpartum depression (PPD) by 3 months after delivery will be determined to be Biomarker Positive by the Enlighten Test in T3. Primary Hypothesis H1b: 10% or fewer of pregnant women who are determined to be Biomarker Negative by the Enlighten Test 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, \& sociocultural context. Specific Aim 2: Comparison of prospective biomarker calls made in blood samples compared to saliva samples using the Enlighten Test. Primary Hypothesis H2: Biomarker calls made using blood versus saliva samples will demonstrate a high concordance rate of 75% or higher. Exploratory Aim 2: In individuals who develop PPD by 3 months postpartum, conduct an epigenome-wide study (EWAS) in saliva to identify saliva-specific epigenetic biomarkers to improve the algorithm's ability to predict PPD using saliva in the third trimester and Week 6 samples. Specific Aim 3: Determination of the utility of the Enlighten Test in identifying women currently experiencing PPD at W6 postpartum. Primary Hypothesis H3: 80% of women who meet criteria for PPD at W6 will be Biomarker Positive. 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 completed by mobile phlebotomists in-person through ExamOne (\~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, and 3 months postpartum for the development of depression symptoms. They'll also complete a multitude of other outcome measures at each of these visits.
Study identification
- NCT ID
- NCT07186309
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,000 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 19, 2025
- Primary completion
- Jul 31, 2029
- Completion
- Jul 31, 2030
- Last update posted
- Nov 27, 2025
2025 – 2030
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07186309, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 27, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07186309 live on ClinicalTrials.gov.