Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD

Study Overview
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Brief Summary
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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. The 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.

Official Title
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Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in Individuals Diagnosed With PTSD

Conditions
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Post Traumatic Stress Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PTSD diagnosis (excluding controls) Proper ability to give informed consent Exclusion Criteria: Active psychotic or suicidal symptoms Active/terminal oncological condition Dialysis patients Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants diagnosed with PTSD<br> | |
| Non-PTSD participants<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cortisol levels | Changes in cortisol levels as measured by the adhesive biosensor patches | 3 months | 
| Changes in c-reactive protein (CRP) | Changes in c-reactive protein (CRP) levels as measured by the adhesive biosensor patches | 3 months | 
| Changes in Interleukin 6 (IL-6) levels | Changes in Interleukin 6 (IL-6) levels as measured by the adhesive biosensor patches | 3 months | 
| Changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) levels | Changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) levels as measured by the adhesive biosensor patches | 3 months | 
| Changes in 8-Oxo-2'-deoxyguanosine (8-oxo-dg) levels | Changes in 8-Oxo-2'-deoxyguanosine (8-oxo-dg) levels as measured by the adhesive biosensor patches | 3 months | 
| Changes in volatile organic compounds (VOCs) levels | 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 | 3 months | 
| Changes in glucose levels | Changes in glucose levels as measured by the adhesive biosensor patches | 3 months | 
| Correlations between biochemical changes and PTSD clinical symptoms | Correlations between biochemical changes and questionnaire data relating to PTSD clinical symptoms (CGI, CAPS, PHQ, PCL-5, PC-PTSD-5, LEC-5 and BARS). | 3 months |