Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

Post Traumatic Stress Disorders Clinical Trial

Official title:

Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893568
• Other study ID #: 2009/01
• Secondary ID: 2009-A00193-54
• Status: Completed
• Phase: N/A
• First received: May 5, 2009
• Last updated: August 27, 2014
• Start date: April 2009

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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)

Locations

Country	Name	City	State
France	Assistance Publique-Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To verify the hypothesis of a levying of inhibition of the CPFm on the tonsil, in the PTSD		3 years	No
Secondary	Studies of the peripheral, cognitive and central mechanisms, before, then 1 week and 6 months after treatment by CBT or EMDR		3 years	No