Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

NCT ID: NCT00893568

Last Updated: 2014-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

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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

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Conditions

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Post Traumatic Stress Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

Healthy volunteers without treatment

Group Type ACTIVE_COMPARATOR

resonance magnetic imaging (fMRI),

Intervention Type OTHER

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

Psychotraumatized patients treated by Cognitive and Behavioral Therapies (CBT)

Group Type EXPERIMENTAL

resonance magnetic imaging (fMRI),

Intervention Type OTHER

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

Psychotraumatized patients treated by Eye Movement Desensitization and Reprocessing (EMDR)

Group Type EXPERIMENTAL

resonance magnetic imaging (fMRI),

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Assistance Publique-Hopitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2009-A00193-54

Identifier Type: -

Identifier Source: secondary_id

2009/01

Identifier Type: -

Identifier Source: org_study_id

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