Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD

NCT04071132 | Unknown

• 1 other identifier: 6381-19-SMC
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (8)

• Changes in cortisol levels

  Changes in cortisol levels as measured by the adhesive biosensor patches

  3 months

• Changes in c-reactive protein (CRP)

  Changes in c-reactive protein (CRP) levels as measured by the adhesive biosensor patches

  3 months

• Changes in Interleukin 6 (IL-6) levels

  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

  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

  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

  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

  Changes in glucose levels as measured by the adhesive biosensor patches

  3 months

• 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

Study Arms (2)

Participants diagnosed with PTSD

Non-PTSD participants

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• PTSD diagnosis (excluding controls)
• Proper ability to give informed consent

You may not qualify if:

• Active psychotic or suicidal symptoms
• Active/terminal oncological condition
• Dialysis patients
• Pregnancy

Sponsors & Collaborators

• Nadav Goldental: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08