Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
Study NCT ID:
NCT06831968
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Validation of a Predictive Test for Postpartum Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and Saliva Samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with True/False Positive and Negative PPD Outcomes as Assessed by the Enlighten Device', 'timeFrame': '6 months postpartum', 'description': "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.\n\nPrimary 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.\n\nExploratory 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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'Postpartum Depression', 'Predictive Test', 'Blood Test', 'Third Trimester'], 'conditions': ['Postpartum Depression (PPD)', 'Pregnancy']}, 'descriptionModule': {'briefSummary': "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.\n\nUp 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.\n\nThe 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.\n\nThis project will address the following Aim:\n\nAim 1: Prospective collection of true/false positive and negative PPD outcomes through 6 months postpartum.\n\nPrimary 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.\n\nPrimary 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.\n\nExploratory 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.\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 500 pregnant women, aged 18 years or above', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* subject must be pregnant (singleton pregnancy)\n* \\<30 weeks' gestation, age 18 or above\n* able to provide written consent in English\n\nExclusion Criteria:\n\n* The study team and/or PI may exclude anyone deemed unsafe to participate in the protocol."}, 'identificationModule': {'nctId': 'NCT06831968', 'acronym': 'PREVAIL', 'briefTitle': 'Clinical Validation of a Predictive Test for Postpartum Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Clinical Validation of a Predictive Test for Postpartum Depression', 'orgStudyIdInfo': {'id': 'PR230933'}, 'secondaryIdInfos': [{'id': 'HT94252410544', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Enlighten', 'type': 'DIAGNOSTIC_TEST', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott A Sullivan, MD', 'role': 'CONTACT', 'email': 'Scott.Sullivan@inova.org', 'phone': '843-817-9046'}, {'name': 'Miranda Newell, MS', 'role': 'CONTACT', 'email': 'Miranda.newell@inova.org', 'phone': '703-776-4600'}, {'name': 'Scott A Sullivan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inova Health System', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}], 'centralContacts': [{'name': 'Meeta Pangtey, MPH', 'role': 'CONTACT', 'email': 'uwp7jh@uvahealth.org', 'phone': '434-987-7367'}, {'name': 'Lauren A Williamson, PhD', 'role': 'CONTACT', 'email': 'lea6d@uvahealth.org', 'phone': '434-987-7369'}], 'overallOfficials': [{'name': 'Jennifer L Payne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}, {'name': 'Andrea Cubitt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dionysus Digital Health, Inc.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry and Neurobehavioral Sciences', 'investigatorFullName': 'Jennifer L. Payne', 'investigatorAffiliation': 'University of Virginia'}}}}