- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04379648
Assessment of Dissociative Traumatic Disorders (TEDI)
May 6, 2020 updated by: Januel
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: BENCHERIF Youcef, CRA
- Phone Number: 0143093030
- Email: y.bencherif@epsve.fr
Study Contact Backup
- Name: Rusheenthira THAVASEELAN, CRA
- Phone Number: 0143093030
- Email: r.thavaseelan@epsve.fr
Study Locations
-
-
Île De France
-
Neuilly Sur Marne, Île De France, France, 93330
- Recruiting
- Youcef Bencherif
-
Contact:
- Youcef BENCHERIF, CRA
- Phone Number: 0143093030
- Email: y.bencherif@epsve.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient diagnosed with PTSD according to DSM 5 criteria
- Over 18 years of age
- Informed consent signed
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Posttraumatic stress disorder
cohort of patients with Posttraumatic stress disorder PTSD
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post Traumatic Stress
Time Frame: 1 year
|
assessment of the prevalence of dissociative disorders in a cohort of patients with PTSD
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Khalid KALALOU, Psychiatrist, EPS Ville Evrard
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2019
Primary Completion (Anticipated)
September 5, 2020
Study Completion (Anticipated)
September 5, 2021
Study Registration Dates
First Submitted
April 29, 2020
First Submitted That Met QC Criteria
May 6, 2020
First Posted (Actual)
May 7, 2020
Study Record Updates
Last Update Posted (Actual)
May 7, 2020
Last Update Submitted That Met QC Criteria
May 6, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10477M-TEDI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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