Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Assistance Publique Hopitaux De Marseille
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00893568
First received: May 5, 2009
Last updated: January 26, 2010
Last verified: January 2010
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Purpose
The post traumatic stress disorder PTSD arises when the physiological response to stress does not come to its term. This study aims to explore the cognitive, psycho physiological and cerebral mechanisms involved in PTSD, in fear conditioning and face matching tasks, before and after treatment.PTSD patients will be recruited by Pr Jean-Claude Samuelian in his service at the Conception Hospital and by Pr Jean-Michel Azorin in his service at the Sainte Marguerite Hospital (Marseille) and will undergo either CBT or EMDR within those same services. The tasks they will be asked to perform will study the psycho physiological, cognitive and central mechanisms involved in PTSD and its treatment. All in all, 17 healthy controls will be recruited as well as 17 PTSD patients for each of the two treatment group.In terms of perspectives, this study would help isolate neural systems functionally involved in PTSD and its treatment. A better knowledge of those mechanisms would set room for the optimization of the current PTSD treatment.
| Condition | Intervention |
|---|---|
|
Post Traumatic Stress Disorders |
Other: resonance magnetic imaging (fMRI), |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment |
Resource links provided by NLM:
Further study details as provided by Assistance Publique Hopitaux De Marseille:
Primary Outcome Measures:
- To verify the hypothesis of a levying of inhibition of the CPFm on the tonsil, in the PTSD [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Studies of the peripheral, cognitive and central mechanisms, before, then 1 week and 6 months after treatment by CBT or EMDR [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 51 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Healthy volunteers
Healthy volunteers without treatment
|
Other: resonance magnetic imaging (fMRI),
a cerebral study will be performed at the neuroanatomic and functional levels by resonance magnetic imaging (fMRI) realized in three times (before, one week and six months after treatment)
|
|
Experimental: CBT
Psychotraumatized patients treated by Cognitive and Behavioral Therapies (CBT)
|
Other: resonance magnetic imaging (fMRI),
a cerebral study will be performed at the neuroanatomic and functional levels by resonance magnetic imaging (fMRI) realized in three times (before, one week and six months after treatment)
|
|
Experimental: EMDR
Psychotraumatized patients treated by Eye Movement Desensitization and Reprocessing (EMDR)
|
Other: resonance magnetic imaging (fMRI),
a cerebral study will be performed at the neuroanatomic and functional levels by resonance magnetic imaging (fMRI) realized in three times (before, one week and six months after treatment)
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- French speakers
- Not hospitalized grown-up patients suffering from a post-traumatic stress disorder ( PTSD) connected to one event.
- Subjects Controls: grown-up, mated with the patients in age (18 - 50 years; 4 years maximum of difference of age between a patient and his control), in sex and educational level (schooling of the 3rd level, at the level Bac+8; 3 years maximum of difference of educational level between a patient and his control)
Exclusion Criteria:
- Pregnancy
- Feeding
- Nobody under guardianship and grown-up persons being the object of a legal protective measure or not able to express their assent
- Alcoholic or addicted to drugs (including medicines)
- Other neurological disorders or psychiatric that post-traumatic stress disorder (for patients)
- Claustrophobia and contraindications in the IRMf
- Subjects controls, no known psychiatric or neurological pathology, as well as no psychiatric history.
- Persons private of freedom by a court or administrative order, persons hospitalized without assent
- Unability to read French
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893568
Contacts
| Contact: Olivier BLIN | olivier.blin@ap-hm.fr |
Locations
| France | |
| Assistance Publique-Hopitaux de Marseille | Recruiting |
| Marseille, France | |
| Contact: Olivier BLIN olivier.blin@ap-hm.fr | |
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
More Information
No publications provided
| Responsible Party: | Assistance Publique Hopitaux De Marseille |
| ClinicalTrials.gov Identifier: | NCT00893568 History of Changes |
| Other Study ID Numbers: | 2009/01, 2009-A00193-54 |
| Study First Received: | May 5, 2009 |
| Last Updated: | January 26, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Assistance Publique Hopitaux De Marseille:
|
Post traumatic stress disorder PTSD |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013