Post Traumatic Stress Disorder (PTSD)NCT01545505
Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse
A study testing Neuropsychological assessment in people with Post Traumatic Stress Disorder (PTSD), run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
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… Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Post Traumatic Stress Disorder (PTSD)
- What is being tested?
- Neuropsychological assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2012to 30 Dec 2016
- 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de NICE
Nice, 06000
Fondation Lenval
Nice, 06000
CHU de TOULOUSE
Toulouse, 31059
CHU de TOURS
Tours, 37044
About this study
Official title: Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder (PTSD)
- Being tested
- Neuropsychological 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.
Neuropsychological assessmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| In remission phase of PTSD | Other | Patients having suffered from PTSD in the past and in remission od PTSD and their parents Receives: Behavioral: Neuropsychological assessment |
| Activ PTSD | Other | patients suffering from PTSD (Post-traumatic Stress Disorder) and their parents Receives: Behavioral: Neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional score
Go-No/Go and visual search tests
Measured: baseline at the first visit (T0), at 6 months, at 9 months
Secondary outcomes (1)
memory (Grober and Buschke)
Grober and Buschke memory tests
Measured: baseline at the first visit (T0), at 6 months, at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startOct 2012
- Primary completion10 Oct 2013
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel BENOIT, M.D.,PhD, Principal investigator, Psychiatrie, Hôpital Pasteur, CHU de NICEWissam EL HAGE, M.D, PhD, Principal investigator, Psychiatrie, CHU de TOURSFrédérique JOVER, M.D., Principal investigator, CAP, Hôpital St ROCH, CHU de NICEFlorence ASKENAZY, M.D., Principal investigator, Fondation Lenval, NICEPhilippe BIRMES, M.D., Principal investigator, Psychiatrie, CHU de TOULOUSEVirginie BUISSE, M.D., Principal investigator, CAP, Hôpital St Roch, CHU de NICE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545505
- Sponsor's protocol ID
- 11-AOI-09
- Status last verified
- Jun 2026
- First submitted
- 8 Dec 2011
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families
- ClinicalTrials.gov ID
- NCT01545505
- Acronym / sponsor ID
- 11-AOI-09
- Conditions
- Post Traumatic Stress Disorder (PTSD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- 10 Oct 2013 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 6 Mar 2012 (estimated)
- 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.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In remission phase of PTSD | Other | Behavioral: Neuropsychological assessmentPatients having suffered from PTSD in the past and in remission od PTSD and their parents |
| Activ PTSD | Other | Behavioral: Neuropsychological assessmentpatients suffering from PTSD (Post-traumatic Stress Disorder) and their parents |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Neuropsychological assessmentA 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. | Behavioural | Activ PTSD, In remission phase of PTSD |
Primary outcome
Attentional score
Time frame: baseline at the first visit (T0), at 6 months, at 9 months
Go-No/Go and visual search tests
1 secondary outcome
memory (Grober and Buschke)
Time frame: baseline at the first visit (T0), at 6 months, at 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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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.
Michel BENOIT, M.D.,PhD principal investigator
Psychiatrie, Hôpital Pasteur, CHU de NICE
Wissam EL HAGE, M.D, PhD principal investigator
Psychiatrie, CHU de TOURS
Frédérique JOVER, M.D. principal investigator
CAP, Hôpital St ROCH, CHU de NICE
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological assessment in people with Post Traumatic Stress Disorder (PTSD), run by Centre Hospitalier Universitaire de Nice at 4 sites 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attentional score (time frame: baseline at the first visit (T0), at 6 months, at 9 months). 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 17 Jun 2026.