Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD

• Conditions: Post Traumatic Stress Disorder

• Registration Number: NCT04071132
• Lead Sponsor: Nadav Goldental

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study Start: 2019-08
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-25
• Last Update Submitted: 2019-08-25
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28
• Primary Completion: 2020-04
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in c-reactive protein (CRP)	3 months	Changes in c-reactive protein (CRP) levels as measured by the adhesive biosensor patches
Changes in Interleukin 6 (IL-6) levels	3 months	Changes in Interleukin 6 (IL-6) levels as measured by the adhesive biosensor patches
Changes in cortisol levels	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	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	3 months	Changes in glucose levels as measured by the adhesive biosensor patches
Changes in 8-Oxo-2'-deoxyguanosine (8-oxo-dg) levels	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	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	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).