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

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 5, 2009

Last Updated Date

January 26, 2010

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00893568 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

Official Title ^ICMJE

Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Post Traumatic Stress Disorders

Intervention ^ICMJE

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)

Study Arm (s)

Active Comparator: Healthy volunteers
Healthy volunteers without treatment

Intervention: Other: resonance magnetic imaging (fMRI),
Experimental: CBT
Psychotraumatized patients treated by Cognitive and Behavioral Therapies (CBT)

Intervention: Other: resonance magnetic imaging (fMRI),
Experimental: EMDR
Psychotraumatized patients treated by Eye Movement Desensitization and Reprocessing (EMDR)

Intervention: Other: resonance magnetic imaging (fMRI),

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Olivier BLIN

olivier.blin@ap-hm.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00893568

Other Study ID Numbers ^ICMJE

2009/01, 2009-A00193-54

Has Data Monitoring Committee

Responsible Party

Assistance Publique Hopitaux De Marseille

Study Sponsor ^ICMJE

Assistance Publique Hopitaux De Marseille

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Assistance Publique Hopitaux De Marseille

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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