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Completed

NCT Number: NCT00893568

Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

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.

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Key information

Conditions

Post Traumatic Stress Disorders Combat Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique-Hopitaux de Marseille

Marseille, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

resonance magnetic imaging (fMRI),

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)

Primary outcomes

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

    Time frame: 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

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
First posted
May 6, 2009
Registry last updated
Aug 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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