Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00893568
First received: May 5, 2009
Last updated: August 27, 2014
Last verified: August 2014
  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 ]

Enrollment: 62
Study Start Date: April 2009
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00893568     History of Changes
Other Study ID Numbers: 2009/01, 2009-A00193-54
Study First Received: May 5, 2009
Last Updated: August 27, 2014
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:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014