Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD

NCT ID: NCT04071132

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2020-09-30

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants diagnosed with PTSD

No interventions assigned to this group

Non-PTSD participants

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nadav Goldental

OTHER

Sponsor Role: lead

Responsible Party

Nadav Goldental

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

6381-19-SMC

Identifier Type: -

Identifier Source: org_study_id