Stress Disorders, Post-TraumaticGeBra-clinNCT05488418
Clinical Study of Biomarkers of Stress Resilience: Role of ELK1 and GPR56
A study testing Clinical, cognitive and biological tests in people with Stress Disorders, Post-Traumatic and Depressive Disorder, Major, run by Assistance Publique Hopitaux De Marseille at 4 sites in France.
Trial summary
70% of Europeans will be exposed to a potentially traumatic event (PTE). Following this experience, people are likely to develop various psychiatric disorders such as post-traumatic stress disorder (PTSD) or a major depressive episode (MDE). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Depressive Disorder, Major, Anxiety Disorder
- What is being tested?
- Clinical, cognitive and biological tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Sep 2022to 31 Aug 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exposure to a traumatic event within 30 days, as defined by ESA criteria A of the DSM-5
- Signed free and informed consent
- Covered by a health insurance company
- 18 to 65 years at inclusion
- Available for a 12-month period follow-up
- Have the ability to speak, read, and understand French
- Have the ability to complete clinical evaluations and self-report measures at baseline and throughout the study
Who cannot join
- Have any condition for which, in the opinion of the investigator or designee, study participation would not be in their best interest (including but not limited to unstable general medical condition, pregnancy) or that could prevent, limit, or confound the protocol-specified assessments
- One or more criteria for ineligibility for registration on the National Registry of Volunteers for Research Involving Humans (VRB)
- History of stable or non-stable psychiatric illness such as bipolar disorder or schizophrenia or any other pathology that may interfere with the evaluations
- Diagnostic of neurological disorder affecting central nervous system function
- Moderate to severe substance use disorders (>=4/11 as defined in DSM-5) and excluding smoking disorders
- Volunteers under court protection or guardianship
- Unable to give the volunteer informed information, or the volunteer refuses to sign the consent form
- Physiological condition deemed clinically incompatible with the study by the investigator o For subjects undergoing MRI: presence of a contraindication for MRI examination.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hopital de la Conception
Marseille
Marion Dubois
Hopital Sainte Marguerite
Marseille
Raoul Belzeaux, 0491746780 ext. 33, raoul.belzeaux@ap-hm.fr
CHU Montpellier
Montpellier
Philippe Courtet
CHRU de Tours
Tours
Wissam El-Hage
About this study
Official title: Étude Clinique Des Biomarqueurs de la résilience au Stress: rôle d'ELK1 et GPR56
70% of Europeans will be exposed to a potentially traumatic event (PTE). Following this experience, people are likely to develop various psychiatric disorders such as post-traumatic stress disorder (PTSD) or a major depressive episode (MDE). However, not all subjects have the same risk to develop a pathology, and resilience capacities, which depend on multiple factors are difficult to predict. Currently, there are no objective tools to stratify exposed subjects according to their risk of developing pathological responses to stress, which leads to difficulties in allocating means of prevention and treatment.
Recently, new biological hypotheses explaining vulnerability/resilience to stress and depression, implicating the GPR56 and ELK1 genes, have been described. Previous studies have shown that evaluation of the vulnerability risk can be obtained from clinical, cognitive, biological or brain imaging variables, but no study has integrated these different approaches. Therefore, the project presented here aims at integrating behavioral, biological and neuroimaging data to predict the development of psychiatric disease. In this study, a prospective cohort of 255 violent trauma victims will be set up in 3 French cities for a period of 2 years. Eligible subjects will be included in the month following PTE and will be followed longitudinally for 12 months. Evaluations at 1, 3, 6 and 12 months will be performed, during which the subject will complete various clinical and cognitive tests. A blood sample will be collected at each visit to study biological processes including the regulation of genetic and epigenetic expression, in particular the expression of the GPR56 and ELK1 genes in the blood. For eligible subjects a brain MRI will be proposed at the first visit.
We hypothesize that the genetic expression of ELK1 and GPR56 is predictive of the development of psychiatric pathologies at 6 and 12 months post-PTE. The ambition of this project is also to highlight the importance of a multimodal approach integrating a triad of markers (behavioral, biological and neuroimaging) to test this hypothesis.
- Being tested
- Clinical, cognitive and biological tests
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical, cognitive and biological testsOther
Also called Blood sample collection, Cerebral MRI exam
Evaluations at 1, 3, 6 and 12 months post-inclusion will be performed, during which the subject will complete various clinical and cognitive tests.
A blood sample will be collected at each visit to study biological processes including the regulation of genetic and epigenetic expression, in particular the expression of the GPR56 and ELK1 genes in the blood.
For eligible subjects a brain MRI will be proposed at the first visit.
| Study group | Role | What they receive |
|---|---|---|
| Patients exposed to a potentially traumatic event | Experimental | Not described Receives: Other: Clinical, cognitive and biological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of ELK1 and GPR56 mRNA levels separately and in combination for the development of psychiatric symptoms following PTE at 6-month follow-up.
Measured: 6 months
Secondary outcomes (6)
Predictive value of the resilience prognosis of a transcriptomic and epigenetic signature (non-coding RNAs and DNA methylation) including GPR56 and ELK1 non-exclusively for the appearance of psychiatric symptoms following a PTE
Measured: 12 months
Predictive value of structural MRI for the development of psychiatric symptoms following PTE
The AUC value determined by structural MRI prediction ROC curve analysis (morphometric analysis) for the onset of psychiatric symptoms during 6 and then 12 month follow-up period after PTE
Measured: 12 months
Predictive value of measure of cognitive functioning for the development of psychiatric symptoms following PTE
The AUC value determined by ROC curve analysis of the MINI and WHODAS measure of cognitive functioning for the development of psychiatric symptoms at 6 and 12 month follow-up period after PTE.
Measured: 12 months
Predictive value of transcriptomic and epigenetic signature for the development of psychiatric symptoms following PTE
The AUC value determined by ROC curve analysis of a transcriptomic and epigenetic signature predictive of the onset of psychiatric symptoms during 6 and then 12 month follow-up period after PTE
Measured: 12 months
Predictive value of ELISA measurement of GPR56 and ELK1 in serum for the development of psychiatric symptoms following PTE
The AUC value determined by ROC curve analysis of the ELISA measurement of GPR56 and ELK1 in serum for the development of psychiatric symptoms during 6 and then 12 month follow-up period after PTE
Measured: 12 months
Title: Predictive value of heart rate variability measuremen for the development of psychiatric symptoms following PTE
The AUC value determined by ROC curve analysis of the heart rate variability measurement for the onset of psychiatric symptoms during a 6- and then 12-month follow-up period after EFA.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488418
- Sponsor's protocol ID
- RCAPHM21_0492
- Other IDs
- ID-RCB
- Acronym
- GeBra-clin
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Étude Clinique Des Biomarqueurs de la résilience au Stress: rôle d'ELK1 et GPR56
- ClinicalTrials.gov ID
- NCT05488418
- Acronym / sponsor ID
- GeBra-clin / RCAPHM21_0492
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 4 Aug 2022 (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.
70% of Europeans will be exposed to a potentially traumatic event (PTE). Following this experience, people are likely to develop various psychiatric disorders such as post-traumatic stress disorder (PTSD) or a major depressive episode (MDE). However, not all subjects have the same risk to develop a pathology, and resilience capacities, which depend on multiple factors are difficult to predict. Currently, there are no objective tools to stratify exposed subjects according to their risk of developing pathological responses to stress, which leads to difficulties in allocating means of prevention and treatment.
Recently, new biological hypotheses explaining vulnerability/resilience to stress and depression, implicating the GPR56 and ELK1 genes, have been described. Previous studies have shown that evaluation of the vulnerability risk can be obtained from clinical, cognitive, biological or brain imaging variables, but no study has integrated these different approaches. Therefore, the project presented here aims at integrating behavioral, biological and neuroimaging data to predict the development of psychiatric disease. In this study, a prospective cohort of 255 violent trauma victims will be set up in 3 French cities for a period of 2 years. Eligible subjects will be included in the month following PTE and will be followed longitudinally for 12 months. Evaluations at 1, 3, 6 and 12 months will be performed, during which the subject will complete various clinical and cognitive tests. A blood sample will be collected at each visit to study biological processes including the regulation of genetic and epigenetic expression, in particular the expression of the GPR56 and ELK1 genes in the blood. For eligible subjects a brain MRI will be proposed at the first visit.
We hypothesize that the genetic expression of ELK1 and GPR56 is predictive of the development of psychiatric pathologies at 6 and 12 months post-PTE. The ambition of this project is also to highlight the importance of a multimodal approach integrating a triad of markers (behavioral, biological and neuroimaging) to test this hypothesis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients exposed to a potentially traumatic event | Experimental | Other: Clinical, cognitive and biological tests |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Exposure to a traumatic event within 30 days, as defined by ESA criteria A of the DSM-5
- Signed free and informed consent
- Covered by a health insurance company
- 18 to 65 years at inclusion
- Available for a 12-month period follow-up
Key exclusion criteria (8 listed)
- Have any condition for which, in the opinion of the investigator or designee, study participation would not be in their best interest (including but not limited to unstable general medical condition, pregnancy) or that could prevent, limit, or confound the protocol-specified assessments
- One or more criteria for ineligibility for registration on the National Registry of Volunteers for Research Involving Humans (VRB)
- History of stable or non-stable psychiatric illness such as bipolar disorder or schizophrenia or any other pathology that may interfere with the evaluations
- Diagnostic of neurological disorder affecting central nervous system function
- Moderate to severe substance use disorders (>=4/11 as defined in DSM-5) and excluding smoking disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical, cognitive and biological testsAlso: Blood sample collection, Cerebral MRI examEvaluations at 1, 3, 6 and 12 months post-inclusion will be performed, during which the subject will complete various clinical and cognitive tests. A blood sample will be collected at each visit to study biological processes including the regulation of genetic and epigenetic expression, in particular the expression of the GPR56 and ELK1 genes in the blood. For eligible subjects a brain MRI will be proposed at the first visit. | Other | Patients exposed to a potentially traumatic event |
Primary outcome
Predictive value of ELK1 and GPR56 mRNA levels separately and in combination for the development of psychiatric symptoms following PTE at 6-month follow-up.
Time frame: 6 months
6 secondary outcomes
Predictive value of the resilience prognosis of a transcriptomic and epigenetic signature (non-coding RNAs and DNA methylation) including GPR56 and ELK1 non-exclusively for the appearance of psychiatric symptoms following a PTE
Time frame: 12 months
Predictive value of structural MRI for the development of psychiatric symptoms following PTE
Time frame: 12 months
Predictive value of measure of cognitive functioning for the development of psychiatric symptoms following PTE
Time frame: 12 months
Predictive value of transcriptomic and epigenetic signature for the development of psychiatric symptoms following PTE
Time frame: 12 months
Predictive value of ELISA measurement of GPR56 and ELK1 in serum for the development of psychiatric symptoms following PTE
Time frame: 12 months
Title: Predictive value of heart rate variability measuremen for the development of psychiatric symptoms following PTE
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
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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.
François CREMIEUX study director
Assistance Publique Hopitaux De Marseille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical, cognitive and biological tests in people with Stress Disorders, Post-Traumatic and Depressive Disorder, Major, run by Assistance Publique Hopitaux De Marseille at 4 sites in France.
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 7 inclusion and 8 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 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Raoul BELZEAUX (0491746780 ext. 33, Raoul.Belzeaux@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of ELK1 and GPR56 mRNA levels separately and in combination for the development of psychiatric symptoms following PTE at 6-month follow-up. (time frame: 6 months). 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 5 Aug 2022.