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

NCT01545505 | Unknown

• 1 other identifier: 11-AOI-09
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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.

Conditions

Post Traumatic Stress Disorder (PTSD)

Outcome Measures

Primary Outcomes (1)

• Attentional score

  Go-No/Go and visual search tests

  baseline at the first visit (T0), at 6 months, at 9 months

Secondary Outcomes (1)

• memory (Grober and Buschke)

  baseline at the first visit (T0), at 6 months, at 9 months

Study Arms (2)

In remission phase of PTSD

OTHER

Patients having suffered from PTSD in the past and in remission od PTSD and their parents

Behavioral: Neuropsychological assessment

Activ PTSD

OTHER

patients suffering from PTSD (Post-traumatic Stress Disorder) and their parents

Behavioral: Neuropsychological assessment

Interventions

Neuropsychological assessment BEHAVIORAL

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; In remission phase of PTSD

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Children who have a neurological pathology.
• Children who have brain damage or brain-injured

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (4)

CHU de NICE

Nice, 06000, France

RECRUITING

Fondation Lenval

Nice, 06000, France

RECRUITING

CHU de TOULOUSE

Toulouse, 31059, France

NOT YET RECRUITING

CHU de TOURS

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel BENOIT, PhD

CONTACT

benoit.m@chu-nice.fr

morgane gindt

CONTACT

morganegindt@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: March 6, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: July 1, 2014
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

FR (4)