Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT04071132
Status:
UNKNOWN
Last Update Posted:
2019-08-28
First Post:
2019-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-25', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-08-25', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in cortisol levels', 'timeFrame': '3 months', 'description': 'Changes in cortisol levels as measured by the adhesive biosensor patches'}, {'measure': 'Changes in c-reactive protein (CRP)', 'timeFrame': '3 months', 'description': 'Changes in c-reactive protein (CRP) levels as measured by the adhesive biosensor patches'}, {'measure': 'Changes in Interleukin 6 (IL-6) levels', 'timeFrame': '3 months', 'description': 'Changes in Interleukin 6 (IL-6) levels as measured by the adhesive biosensor patches'}, {'measure': 'Changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) levels', 'timeFrame': '3 months', 'description': 'Changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) levels as measured by the adhesive biosensor patches'}, {'measure': "Changes in 8-Oxo-2'-deoxyguanosine (8-oxo-dg) levels", 'timeFrame': '3 months', 'description': "Changes in 8-Oxo-2'-deoxyguanosine (8-oxo-dg) levels as measured by the adhesive biosensor patches"}, {'measure': 'Changes in volatile organic compounds (VOCs) levels', 'timeFrame': '3 months', 'description': 'Changes in volatile organic compounds (VOCs) concentrations (hexanone, acetic acid, heptane, hexanal, 3-heptanone, hexanoic acid, heptanal and nonanal) as measured by the adhesive biosensor patches'}, {'measure': 'Changes in glucose levels', 'timeFrame': '3 months', 'description': 'Changes in glucose levels as measured by the adhesive biosensor patches'}, {'measure': 'Correlations between biochemical changes and PTSD clinical symptoms', 'timeFrame': '3 months', 'description': 'Correlations between biochemical changes and questionnaire data relating to PTSD clinical symptoms (CGI, CAPS, PHQ, PCL-5, PC-PTSD-5, LEC-5 and BARS).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'A psychiatric diagnosis of post-traumatic stress disorder (PTSD) is currently based mainly on non-quantitative elements, such as interviews and subjective impressions. PTSD has physiological manifestations, some of which are likely reflected in the levels and ratios of certain stress-related proteins in the interstitial fluid and plasma. Discernable patterns of such stress-related proteins may constitute a biochemical phenotype characteristic of PTSD, which may serve as a biomarker and support diagnostic decisions, as well as personalized treatment plans.\n\nThe current study is a non-interventional observational study aimed at examining the possibility of basing a psychiatric diagnosis by measuring changes in the biochemical phenotype of participants with PTSD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult (aged 18 and over) participants with and without PTSD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PTSD diagnosis (excluding controls)\n* Proper ability to give informed consent\n\nExclusion Criteria:\n\n* Active psychotic or suicidal symptoms\n* Active/terminal oncological condition\n* Dialysis patients\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04071132', 'briefTitle': 'Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD', 'organization': {'class': 'OTHER', 'fullName': 'The Chaim Sheba Medical Center'}, 'officialTitle': 'Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in Individuals Diagnosed With PTSD', 'orgStudyIdInfo': {'id': '6381-19-SMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants diagnosed with PTSD'}, {'label': 'Non-PTSD participants'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nadav Goldental', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nadav Goldental', 'investigatorAffiliation': 'The Chaim Sheba Medical Center'}}}}