Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in Individuals Diagnosed With PTSD
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Nadav Goldental
- Enrollment
- 50
- Primary Endpoint
- Changes in c-reactive protein (CRP)
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 c-reactive protein (CRP)
Time Frame: 3 months
Changes in c-reactive protein (CRP) levels as measured by the adhesive biosensor patches
Changes in Interleukin 6 (IL-6) levels
Time Frame: 3 months
Changes in Interleukin 6 (IL-6) levels as measured by the adhesive biosensor patches
Changes in cortisol levels
Time Frame: 3 months
Changes in cortisol levels as measured by the adhesive biosensor patches
Changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) levels
Time Frame: 3 months
Changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) levels as measured by the adhesive biosensor patches
Changes in glucose levels
Time Frame: 3 months
Changes in glucose levels as measured by the adhesive biosensor patches
Changes in 8-Oxo-2'-deoxyguanosine (8-oxo-dg) levels
Time Frame: 3 months
Changes in 8-Oxo-2'-deoxyguanosine (8-oxo-dg) levels as measured by the adhesive biosensor patches
Changes in volatile organic compounds (VOCs) levels
Time Frame: 3 months
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
Correlations between biochemical changes and PTSD clinical symptoms
Time Frame: 3 months
Correlations between biochemical changes and questionnaire data relating to PTSD clinical symptoms (CGI, CAPS, PHQ, PCL-5, PC-PTSD-5, LEC-5 and BARS).
Secondary Outcomes
No secondary outcomes reported
Investigators
Nadav Goldental
Principal investigator
The Chaim Sheba Medical Center