Post Traumatic Stress DisorderNCT04071132
Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in PTSD
An observational study of Post Traumatic Stress Disorder, run by Nadav Goldental.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult (aged 18 and over) participants with and without PTSD
Who may be able to join
- PTSD diagnosis (excluding controls)
- Proper ability to give informed consent
Who cannot join
- Active psychotic or suicidal symptoms
- Active/terminal oncological condition
- Dialysis patients
- Pregnancy
About this study
Official title: 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.
- Conditions
- Post Traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants diagnosed with PTSD | Not described | |
| Non-PTSD participants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cortisol levels
Changes in cortisol levels as measured by the adhesive biosensor patches
Measured: 3 months
Changes in c-reactive protein (CRP)
Changes in c-reactive protein (CRP) levels as measured by the adhesive biosensor patches
Measured: 3 months
Changes in Interleukin 6 (IL-6) levels
Changes in Interleukin 6 (IL-6) levels as measured by the adhesive biosensor patches
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Changes in glucose levels
Changes in glucose levels as measured by the adhesive biosensor patches
Measured: 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startAug 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nadav Goldental
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nadav Goldental, The Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071132
- Sponsor's protocol ID
- 6381-19-SMC
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Adhesive Biosensor Patches to Characterize the Biochemical Phenotype in Individuals Diagnosed With PTSD
- ClinicalTrials.gov ID
- NCT04071132
- Acronym / sponsor ID
- 6381-19-SMC
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nadav GoldentalUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants diagnosed with PTSD | – | – |
| Non-PTSD participants | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (aged 18 and over) participants with and without PTSD
Key inclusion criteria (2 listed)
- PTSD diagnosis (excluding controls)
- Proper ability to give informed consent
Key exclusion criteria (4 listed)
- Active psychotic or suicidal symptoms
- Active/terminal oncological condition
- Dialysis patients
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in cortisol levels
Time frame: 3 months
Changes in cortisol levels as measured by the adhesive biosensor patches
Changes in c-reactive protein (CRP)
Time frame: 3 months
Changes in c-reactive protein (CRP) levels as measured by the adhesive biosensor patches
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
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
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
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
Changes in glucose levels
Time frame: 3 months
Changes in glucose levels as measured by the adhesive biosensor patches
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder, run by Nadav Goldental.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cortisol levels (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019; AzTrials last refreshed its copy on 1 Nov 2026.