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Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse

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ClinicalTrials.gov Identifier: NCT01545505
Recruitment Status : Unknown
Verified February 2013 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : March 6, 2012
Last Update Posted : February 21, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief Summary:
Relapse of post-traumatic stress disorder (PTSD) remains challenging. In addition, factors predicting PTSD relapse are still unknown. The aim of this study is to examine whether clinical and neuropsychological changes (e.g., attentional bias toward aversive cues) that characterized PTSD can be observed in people with past PTSD (children and their families) and whether these persistent changes are predictive of PTSD relapse.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder (PTSD) Behavioral: Neuropsychological assessment Not Applicable

Detailed Description:

One of the great challenges in Psychotraumatology is the high risk (20-40%) of post-traumatic stress disorder (PTSD) relapse, which markers remain understudied. Identification of these markers is of particular interest for the development of strategies to prevent relapse. Based on clinical and experimental data, it appears that (i) the so-called residual clinical symptoms (such as sleep disturbance, irritability) and (ii) the neuropsychological dysfunctions (cognitive difficulties), persisting after remission, may constitute markers of PTSD relapse. Moreover, all of these potential markers have also been linked with dysfunctions, persisting or reoccurring, in the prefrontal cortex after remission.

The main objective of this study is to identify these clinical and neuropsychological markers of PTSD relapse in children and their families. The secondary objective is to demonstrate the link between prefrontal dysfunctions and relapse.

This longitudinal study will include 4 experimental groups:

  • 30 children with PTSD
  • 30 children with past PTSD (children in remission)
  • 30 parents of children with PTSD
  • 30 parents of children with past PTSD The first visit is planned during the symptomatic phase (T0). The second visit (T1) is planned at the end of the symptomatic phase (or 6 months later T0). The last visit is planned 3-months after T1.

The psychological assessment will include:

A structured interview with a psychiatrist An assessment of PTSD symptoms (IES-R, CPTS-RI for children) An assessment of the co-morbidity (STAI C and CDI for children, STAI A-B, BDI for adults).

An evaluation of the social life (EAS for children and SAS-SR for adults).

The neuropsychological assessment will include:

An evaluation of the attentional treatment (Go-No / go and visual search) An evaluation of executive functions (TMT A and B) A brief evaluation of the IQ (items memory of figures, matrix and resemblance) An evaluation of the memory (Grober and Buschke) Tests include an adult and children versions that are validated. All studies will be conducted at the Nice University Hospital, Tours University Hospital and Toulouse University Hospital.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families
Study Start Date : October 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
In remission phase of PTSD
Patients having suffered from PTSD in the past and in remission od PTSD and their parents
 Behavioral: Neuropsychological assessment

A clinical evaluation with Impact of Events Scale-Revised, Child Post-Traumatic Stress Reaction Index, State-Trait Anxiety Inventory for Children, Children Depression Inventory and Emotion, activity and sociability.

A neuropsychological assessment with a emotional Go-No/Go, a visual search task, the Trail Making Test, 3 items of the WISC III ( and the Grober and Buschke Test.
Activ PTSD
patients suffering from PTSD (Post-traumatic Stress Disorder) and their parents
 Behavioral: Neuropsychological assessment

A clinical evaluation with Impact of Events Scale-Revised, Child Post-Traumatic Stress Reaction Index, State-Trait Anxiety Inventory for Children, Children Depression Inventory and Emotion, activity and sociability.

A neuropsychological assessment with a emotional Go-No/Go, a visual search task, the Trail Making Test, 3 items of the WISC III ( and the Grober and Buschke Test.


Outcome Measures
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Primary Outcome Measures :
  1. Attentional score [ Time Frame: baseline at the first visit (T0), at 6 months, at 9 months ]
    Go-No/Go and visual search tests


Secondary Outcome Measures :
  1. memory (Grober and Buschke) [ Time Frame: baseline at the first visit (T0), at 6 months, at 9 months ]
    Grober and Buschke memory tests


Eligibility Criteria
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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For children

Inclusion Criteria:

  • Children (9/18 years)
  • Patients who have lived a traumatic event (physical assault and road accident) and who have a PTSD.
  • French speaker.
  • Participants must sign the informed consent and they must be affiliated to the social insurance.

Exclusion Criteria

  • Children who have a neurological pathology.
  • Children who have brain damage or brain-injured
  • Subject having participated in a biomedical research in three months preceding the inclusion
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545505


Contacts
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Contact: Michel BENOIT, PhD benoit.m@chu-nice.fr
Contact: morgane gindt morganegindt@yahoo.fr

Locations
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France
CHU de NICE Recruiting
Nice, France, 06000
Contact: Michel BENOIT, M.D., PhD       benoit.m@chu-nice.fr   
Principal Investigator: Michel BENOIT, M.D., PhD         
Principal Investigator: Frédérique JOVER, M.D.         
Sub-Investigator: Virginie BUISSE, M.D, PhD         
Fondation Lenval Recruiting
Nice, France, 06000
Contact: florence Askenazy, M.D.       florence.askenazy@lenval.com   
CHU de TOULOUSE Not yet recruiting
Toulouse, France, 31059
Principal Investigator: Philippe BIRMES, M.D.         
CHU de TOURS Recruiting
Tours, France, 37044
Principal Investigator: Wissam EL HAGE, M.D., PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Michel BENOIT, M.D.,PhD Psychiatrie, Hôpital Pasteur, CHU de NICE
Principal Investigator: Wissam EL HAGE, M.D, PhD Psychiatrie, CHU de TOURS
Principal Investigator: Frédérique JOVER, M.D. CAP, Hôpital St ROCH, CHU de NICE
Principal Investigator: Florence ASKENAZY, M.D. Fondation Lenval, NICE
Principal Investigator: Philippe BIRMES, M.D. Psychiatrie, CHU de TOULOUSE
Principal Investigator: Virginie BUISSE, M.D. CAP, Hôpital St Roch, CHU de NICE
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01545505    
Other Study ID Numbers: 11-AOI-09
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders