Back to search results

Observational Study of Enlighten Device for Postpartum Depression

This study is looking for up to 500 pregnant women to help develop a blood test called Enlighten. This test aims to predict the risk of postpartum depression (PPD) before it happens. Researchers will collect blood samples during your pregnancy and then check for symptoms of depression up to three months after you give birth. The main goal is to see how accurately the Enlighten test identifies women who will or will not experience PPD. You must be at least 18 years old, pregnant with one baby, and able to give written consent in English. Please note, this blood test is still being studied and is not yet approved by the FDA, and you will not receive your test results.

Study design
This is an observational study involving up to 500 pregnant women. It is not a treatment study but rather aims to validate a diagnostic test.
What's involved
You will provide blood samples during pregnancy. Researchers will then collect information on your depression symptoms up to three months after childbirth.
Compensation
Not stated in the trial record.
Follow-up
Your PPD outcomes will be assessed by the Enlighten Device at 6 months postpartum.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06831968

Clinical Validation of a Predictive Test for Postpartum Depression

Recruiting
Not specifiedAges 18+Observational
University of Virginia
~500 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:Enlighten

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with True/False Positive and Negative PPD Outcomes as Assessed by the Enlighten Device
Measured over 6 months postpartum

Conditions

Postpartum Depression (PPD)
Pregnancy

Explore related trials

Postpartum DepressionPregnancy

Where it's being run

2 sites across 1 states
Virginia2

Study leadership

  • Jennifer L Payne, MD · PRINCIPAL_INVESTIGATOR · University of Virginia
  • Andrea Cubitt, PhD · PRINCIPAL_INVESTIGATOR · Dionysus Digital Health, Inc.

Who to contact

Meeta Pangtey, MPH
[email protected]
434-987-7367
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

subject must be pregnant (singleton pregnancy)
\<30 weeks' gestation, age 18 or above
able to provide written consent in English

Exclusion

The study team and/or PI may exclude anyone deemed unsafe to participate in the protocol.

What this trial measures

  • Percentage of Participants with True/False Positive and Negative PPD Outcomes as Assessed by the Enlighten Device6 months postpartum

    PPD diagnosis will be confirmed by clinical evaluation using the Structured Clinical Interview for the DSM-5 Research Version (SCID-5-RV) and Edinburgh Postnatal Depression Scale (EPDS), at the time of enrollment and subsequent study visits. True positive/negative and false positive/negative classifications will be based on the Enlighten Device's biomarker threshold values in T3 (third trimester). Data will be aggregated as percentages and compared to clinical PPD diagnoses. 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.