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Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04071132
Enrollment
50
Registered
2019-08-28
Start date
2019-08-31
Completion date
2020-09-30
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

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.

Interventions

None listed

Sponsors

Nadav Goldental
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Changes in c-reactive protein (CRP)3 monthsChanges in c-reactive protein (CRP) levels as measured by the adhesive biosensor patches
Changes in Interleukin 6 (IL-6) levels3 monthsChanges in Interleukin 6 (IL-6) levels as measured by the adhesive biosensor patches
Changes in cortisol levels3 monthsChanges in cortisol levels as measured by the adhesive biosensor patches
Changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) levels3 monthsChanges in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) levels as measured by the adhesive biosensor patches
Changes in 8-Oxo-2'-deoxyguanosine (8-oxo-dg) levels3 monthsChanges in 8-Oxo-2'-deoxyguanosine (8-oxo-dg) levels as measured by the adhesive biosensor patches
Changes in volatile organic compounds (VOCs) levels3 monthsChanges 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
Changes in glucose levels3 monthsChanges in glucose levels as measured by the adhesive biosensor patches
Correlations between biochemical changes and PTSD clinical symptoms3 monthsCorrelations between biochemical changes and questionnaire data relating to PTSD clinical symptoms (CGI, CAPS, PHQ, PCL-5, PC-PTSD-5, LEC-5 and BARS).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026