Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD

August 25, 2019 updated by: Nadav Goldental

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

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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult (aged 18 and over) participants with and without PTSD

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants diagnosed with PTSD
Non-PTSD participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cortisol levels
Time Frame: 3 months
Changes in cortisol levels as measured by the adhesive biosensor patches
3 months
Changes in c-reactive protein (CRP)
Time Frame: 3 months
Changes in c-reactive protein (CRP) levels as measured by the adhesive biosensor patches
3 months
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
3 months
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
3 months
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
3 months
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
3 months
Changes in glucose levels
Time Frame: 3 months
Changes in glucose levels as measured by the adhesive biosensor patches
3 months
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nadav Goldental

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 25, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 25, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6381-19-SMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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