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NCT04071132 Clinical Trial

Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD

Post Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04071132
Other study ID # 6381-19-SMC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2019
Est. completion date September 2020

Study information
Verified date August 2019
Source The Chaim Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date September 2020
Est. primary completion date April 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nadav Goldental

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in cortisol levels Changes in cortisol levels as measured by the adhesive biosensor patches 3 months
Primary Changes in c-reactive protein (CRP) Changes in c-reactive protein (CRP) levels as measured by the adhesive biosensor patches 3 months
Primary Changes in Interleukin 6 (IL-6) levels Changes in Interleukin 6 (IL-6) levels as measured by the adhesive biosensor patches 3 months
Primary 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
Primary 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
Primary 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
Primary Changes in glucose levels Changes in glucose levels as measured by the adhesive biosensor patches 3 months
Primary 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
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