Posttraumatic Stress DisorderTEDINCT04379648
Assessment of Dissociative Traumatic Disorders
A study testing self-assessment and hetero-assessment in people with Posttraumatic Stress Disorder, run by Januel at 1 site in France.
Trial summary
More than 70% of ambulatory patients with IDD have attempted suicide (APA, 2015). This disorder, as well as all the disorders on the dissociation spectrum, must therefore be clarified and better diagnosed. The goal of this research is : 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- self-assessment and hetero-assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2019to 5 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with PTSD according to DSM 5 criteria
- Over 18 years of age
- Informed consent signed
Who cannot join
- Neurological disorders
- Serious and/or unstable somatic pathologies
- Patient not affiliated with social security
- Patient hospitalized under restraint in psychiatric care by decision of the state representative or in psychiatric care at the request of a third party
- Patient under guardianship
- Patient participating in parallel in another biomedical research
- Change of antidepressant in the last three months
- Patient not mastering the French language
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Youcef BENCHERIF
Neuilly-sur-Marne, Île-de-France Region, 93330
Youcef BENCHERIF, CRA, 0143093030, y.bencherif@epsve.fr
About this study
More than 70% of ambulatory patients with IDD have attempted suicide (APA, 2015). This disorder, as well as all the disorders on the dissociation spectrum, must therefore be clarified and better diagnosed.
The goal of this research is :
- to assess the prevalence of dissociative disorders using specific tools in patients suffering from PTSD.
- to validate the French version of the DDIS interview (Ross, 1997) that the investigators have translated.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- self-assessment and hetero-assessment
- 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.
self-assessment and hetero-assessmentOther
Self assessment for the passing of the following rating scales CTQ-SF36-ITQ-PCL5-DES Hetero-assessment for the pasing of the following rating scales DDIS FR and medical interview
| Study group | Role | What they receive |
|---|---|---|
| Posttraumatic stress disorder | Other | cohort of patients with Posttraumatic stress disorder PTSD Receives: Other: self-assessment and hetero-assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Traumatic Stress
assessment of the prevalence of dissociative disorders in a cohort of patients with PTSD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start5 Feb 2019
- Primary completion5 Sep 2020 (estimated)
- Study completion5 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients with a diagnosis of Post Traumatic Stress Disorder will be seen by a physician psychiatrist or psychologist who will introduce them to the study. They will be given an information letter and a consent form. If patients agree to participate in the study, and after signing the consent form, they will be included and will complete the assessment scales.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Januel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Januel, Centre hospitalier de Ville-Evrard, France
- Investigators
- Khalid KALALOU, Psychiatrist, Principal investigator, EPS Ville Evrard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379648
- Sponsor's protocol ID
- 10477M-TEDI
- Acronym
- TEDI
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dissociative Traumatic Disorders
- ClinicalTrials.gov ID
- NCT04379648
- Acronym / sponsor ID
- TEDI / 10477M-TEDI
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- JanuelUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 5 Sep 2020 (estimated)
- Study completion
- 5 Sep 2021 (estimated)
- First posted
- 7 May 2020 (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.
More than 70% of ambulatory patients with IDD have attempted suicide (APA, 2015). This disorder, as well as all the disorders on the dissociation spectrum, must therefore be clarified and better diagnosed.
The goal of this research is :
- to assess the prevalence of dissociative disorders using specific tools in patients suffering from PTSD.
- to validate the French version of the DDIS interview (Ross, 1997) that the investigators have translated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients with a diagnosis of Post Traumatic Stress Disorder will be seen by a physician psychiatrist or psychologist who will introduce them to the study. They will be given an information letter and a consent form. If patients agree to participate in the study, and after signing the consent form, they will be included and will complete the assessment scales.
| Arm | Type | Receives |
|---|---|---|
| Posttraumatic stress disorder | Other | Other: self-assessment and hetero-assessmentcohort of patients with Posttraumatic stress disorder PTSD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient diagnosed with PTSD according to DSM 5 criteria
- Over 18 years of age
- Informed consent signed
Key exclusion criteria (8 listed)
- Neurological disorders
- Serious and/or unstable somatic pathologies
- Patient not affiliated with social security
- Patient hospitalized under restraint in psychiatric care by decision of the state representative or in psychiatric care at the request of a third party
- Patient under guardianship
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 |
|---|---|---|
| self-assessment and hetero-assessmentSelf assessment for the passing of the following rating scales CTQ-SF36-ITQ-PCL5-DES Hetero-assessment for the pasing of the following rating scales DDIS FR and medical interview | Other | Posttraumatic stress disorder |
Primary outcome
Post Traumatic Stress
Time frame: 1 year
assessment of the prevalence of dissociative disorders in a cohort of patients with PTSD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
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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.
Khalid KALALOU, Psychiatrist principal investigator
EPS Ville Evrard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-assessment and hetero-assessment in people with Posttraumatic Stress Disorder, run by Januel at 1 site 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 3 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 BENCHERIF Youcef, CRA (0143093030, y.bencherif@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Traumatic Stress (time frame: 1 year). 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 7 May 2020.