Clinical Validation of a Predictive Test for Postpartum Depression

NCT06831968 | Recruiting DMC

• 2 other identifiers: PR230933HT94252410544
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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, 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.

Conditions

Postpartum Depression (PPD); Pregnancy

Keywords

Pregnancy; Postpartum Depression; Predictive Test; Blood Test; Third Trimester

Outcome Measures

Primary Outcomes (1)

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

  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.

  6 months postpartum

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Up to 500 pregnant women, aged 18 years or above

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (2)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Inova Health System

Falls Church, Virginia, 22042, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Saliva Samples

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Jennifer L Payne, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Andrea Cubitt, PhD

  Dionysus Digital Health, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meeta Pangtey, MPH

CONTACT

434-987-7367; uwp7jh@uvahealth.org

Lauren A Williamson, PhD

CONTACT

434-987-7369; lea6d@uvahealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Neurobehavioral Sciences

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 18, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (2)