Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD

Nadav Goldental50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Post Traumatic Stress Disorder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes in cortisol levels

Changes in cortisol levels as measured by the adhesive biosensor patches

Time frame: 3 months

Changes in c-reactive protein (CRP)

Changes in c-reactive protein (CRP) levels as measured by the adhesive biosensor patches

Time frame: 3 months

Changes in Interleukin 6 (IL-6) levels

Changes in Interleukin 6 (IL-6) levels as measured by the adhesive biosensor patches

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 3 months

Changes in glucose levels

Changes in glucose levels as measured by the adhesive biosensor patches

Time frame: 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).

Time frame: 3 months

Data from ClinicalTrials.gov

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