NCT00893568

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

3.1 years

First QC Date

May 5, 2009

Last Update Submit

August 27, 2014

Conditions

Keywords

Post traumatic stress disorder PTSD

Outcome Measures

Primary Outcomes (1)

  • To verify the hypothesis of a levying of inhibition of the CPFm on the tonsil, in the PTSD

    3 years

Secondary Outcomes (1)

  • Studies of the peripheral, cognitive and central mechanisms, before, then 1 week and 6 months after treatment by CBT or EMDR

    3 years

Study Arms (3)

Healthy volunteers

ACTIVE COMPARATOR

Healthy volunteers without treatment

Other: resonance magnetic imaging (fMRI),

CBT

EXPERIMENTAL

Psychotraumatized patients treated by Cognitive and Behavioral Therapies (CBT)

Other: resonance magnetic imaging (fMRI),

EMDR

EXPERIMENTAL

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

Other: resonance magnetic imaging (fMRI),

Interventions

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)

CBTEMDRHealthy volunteers

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique-Hopitaux de Marseille

Marseille, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticCombat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 6, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2012

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations