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

Post Traumatic Stress Disorder (PTSD) Clinical Trial

Official title:

Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01545505
• Other study ID #: 11-AOI-09
• Status: Recruiting
• Phase: N/A
• First received: December 8, 2011
• Last updated: February 20, 2013
• Start date: October 2012
• Est. completion date: July 2014

Study information

• Verified date: February 2013
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Michel BENOIT, PhD
• Email: benoit.m[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
France	CHU de NICE	Nice
France	Fondation Lenval	Nice
France	CHU de TOULOUSE	Toulouse
France	CHU de TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attentional score	Go-No/Go and visual search tests	baseline at the first visit (T0), at 6 months, at 9 months	No
Secondary	memory (Grober and Buschke)	Grober and Buschke memory tests	baseline at the first visit (T0), at 6 months, at 9 months	No