Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment - Full Text View

Sponsored by:	Assistance Publique Hopitaux De Marseille
Information provided by:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00893568

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),

MedlinePlus related topics: Post-Traumatic Stress Disorder Tonsils and Adenoids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Parallel Assignment
Official Title:	Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

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
Healthy volunteers: Active Comparator 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)
CBT: Experimental 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)
EMDR: Experimental 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

Locations

France
Assistance Publique-Hopitaux de Marseille
Marseille, France

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

More Information

No publications provided

Responsible Party:	( Assistance Publique Hopitaux De Marseille )
Study ID Numbers:	2009/01, 2009-A00193-54
Study First Received:	May 5, 2009
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00893568 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Assistance Publique Hopitaux De Marseille:

Post traumatic stress disorder PTSD

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on May 07, 2009