Postpartum Depression (PPD)BRAVENCT07186309
A Study of a Test for Postpartum Depression at Home
An observational study of Postpartum Depression (PPD) and Pregnancy, run by University of Virginia at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression (PPD), Pregnancy
- What is being tested?
- Diagnostic Test: Enlighten
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2025to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 1,000 pregnant women aged 18 and older up to 33 weeks of gestation
Who may be able to join
- subject must be pregnant (singleton pregnancy)
- <30 weeks' gestation, age 18 or above
- able to provide written consent in English
Who cannot join
- The study team and/or PI may exclude anyone deemed unsafe to participate in the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: A Prospective Validation of the Enlighten Device in Predicting Postpartum Depression Using At-Home Sample Collection in Both Blood and Saliva
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.
Read more
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.
- Conditions
- Postpartum Depression (PPD), Pregnancy
- Being tested
- Diagnostic Test: Enlighten
- Keywords
- Pregnancy, Postpartum Depression, Predictive Test, Blood Test, Third Trimester, Behavioral Symptoms, Mood Disorders, Mental Disorders, Puerperal Disorders, Pregnancy Complications, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Depression, Postpartum, Depression, Depressive Disorder
- Medical subject headings
- Depression, Postpartum, Behavioral Symptoms, Mood Disorders, Mental Disorders, Puerperal Disorders, Pregnancy Complications, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: EnlightenDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start20 Nov 2025
- Primary completionAug 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Dionysus Health
- Responsible party
- Principal investigator, Jennifer L. Payne, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186309
- Sponsor's protocol ID
- 20252779
- Other IDs
- HT94252510260
- Acronym
- BRAVE
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The investigators plan to share de-identified data with other researchers. Data shared will include demographic information, clinical data which will include SCID diagnosis, mental health surveys like EPDS, PASS, etc., sample analyses data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Validation of the Enlighten Device in Predicting Postpartum Depression Using At-Home Sample Collection in Both Blood and Saliva
- ClinicalTrials.gov ID
- NCT07186309
- Acronym / sponsor ID
- BRAVE / 20252779
- Conditions
- Postpartum Depression (PPD), Pregnancy
- Keywords
- Pregnancy, Postpartum Depression, Predictive Test, Blood Test, Third Trimester, Behavioral Symptoms, Mood Disorders, Mental Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Mayo Clinic, Dionysus Health
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 1,000 pregnant women aged 18 and older up to 33 weeks of gestation
Key inclusion criteria (3 listed)
- subject must be pregnant (singleton pregnancy)
- <30 weeks' gestation, age 18 or above
- able to provide written consent in English
Key exclusion criteria (1 listed)
- The study team and/or PI may exclude anyone deemed unsafe to participate in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: EnlightenThe 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. | Device | – |
Primary outcome
Percentage of Participants with True/False Positive and Negative PPD Outcomes as Assessed by the Enlighten Device
Time frame: 6 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Yes. The investigators plan to share de-identified data with other researchers. Data shared will include demographic information, clinical data which will include SCID diagnosis, mental health surveys like EPDS, PASS, etc., sample analyses data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression (PPD) and Pregnancy, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meeta Pangtey, MPH (434-987-7367, uwp7jh@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.