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Emotional Memory Reactivation in Posttraumatic Stress Disorder (VIVITRAU)

This study has been terminated.
(Study stopped by promoter for lack of inclusion)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01239173
First Posted: November 11, 2010
Last Update Posted: July 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
October 25, 2010
November 11, 2010
July 26, 2012
September 2010
November 2011   (Final data collection date for primary outcome measure)
Effect of propanolol, a beta adrenergic antagonism, on amygdala activation during a symptom provocation state in traumatized subjects with and without posttraumatic stress disorder [ Time Frame: 34 days ]
Same as current
Complete list of historical versions of study NCT01239173 on ClinicalTrials.gov Archive Site
  • Comparison of propranolol therapeutic effects versus placebo on symptom provocation state in traumatized subjects with and without posttraumatic stress disorder [ Time Frame: 34 days ]
  • Comparison of activated neuronal networks when a patient remember a pleasant , unpleasant or traumatic event [ Time Frame: 34 days ]
  • Comparison of emotional status of traumatized subjects with and without posttraumatic stress disorder [ Time Frame: 34 days ]
Same as current
Not Provided
Not Provided
 
Emotional Memory Reactivation in Posttraumatic Stress Disorder
Reliving the Traumatic Event in Posttraumatic Stress Disorder: An Emotional Memory Reactivation Pathology? An fMRI Study

Converging lines of evidence have implicated the amygdala in the pathophysiology of posttraumatic stress disorder.

The primary purpose of our study is to assess the effect of propanolol, a beta adrenergic antagonism, on amygdala activation during a symptom provocation state in traumatized subjects with and without posttraumatic stress disorder.

Post-traumatic stress disorder (PTSD) is a type of anxiety disorder that's triggered by an extremely traumatic event. Traumatic events that may trigger PTSD include violent personal assaults, accidents, natural or human-caused disasters, or military combat. Converging lines of evidence have implicated the amygdala in the pathophysiology of posttraumatic stress disorder.

Initially based on animal studies, the idea that memory for emotional material in humans is modulated by the noradrenergic system and by the amygdala, has received a strong support over the last decade. Evidence mainly comes from studies investigating the effect of emotion on encoding processes (Mc GAUGH, 2000). In that view, propranolol has been used somewhat successfully shortly after trauma to reduce the development of PTSD symptoms (Pitman et al., 2002; VAIVA et al., 2003). As already mentioned, "reconsolidation" studies developed in rats provide treatment strategies that can be used long after PTSD induction. Recent evidence indicates that consolidated long-term memory in human can also be influenced by events delivered after memory reactivation (Walker et al., 2003; HUPBACH et al., 2007), suggesting that human memory can be retroactively altered by treatments delivered in conjunction with memory reactivation. This seems to be confirmed by an as yet unpublished human based study that suggests that propranolol may impair reconsolidation of conditioned fear-response (Miller et al., 2004) The primary purpose of our study is to assess the effect of propanolol, a beta adrenergic antagonism, on amygdala activation during a symptom provocation state in traumatized subjects with and without posttraumatic stress disorder. One Functional magnetic resonance imaging (fMRI) will be performed (week 1) in 32 patients with PTSD and 32 controls (exposure to a traumatic event without PTSD) to examine amygdala activation during a provocation state.

One half of the patients with PTSD and one half of the controls will receive propranolol prior the fMRI under double blind condition.

In addition, a cognitive test battery will be performed (screening, week 0, 1, 2) before the fRMI acquisition and at follow up visits.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Posttraumatic Stress Disorder
  • Drug: AVLOCARDYL
    A grip of 2 tablets of 20 mg each took 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
  • Drug: Placebo
    A grip of 2 tablets of 20 mg each took 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
  • Active Comparator: 1
    Post-traumatic stress disorder patient receiving propanolol 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
    Intervention: Drug: AVLOCARDYL
  • Placebo Comparator: 2
    Post-traumatic stress disorder receiving placebo 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
    Intervention: Drug: Placebo
  • Active Comparator: 3
    Controls receiving propanolol 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
    Intervention: Drug: AVLOCARDYL
  • Placebo Comparator: 4
    Controls receiving placebo 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
February 2012
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients of French mother language
  • Right-handed patients
  • Signature of the consent

Patients:

  • Patients whose diagnosis of PTSD according to the criteria of the DSM IV-TR is established
  • PTSD whose evolution is not chronic
  • Established PTSD : Symptoms presents for at least 1 month
  • PTSD consecutive to a unique traumatic event

Controls :

  • The healthy controls will have sudden a traumatism of the same nature or the nature comparable to that of the patients suffering from PTSD, but they will not have developed pathology
  • Subjects having undergone a traumatism dating less than 3 months
  • Examples of traumatic events: aggression, accident of the public highway, the occupational accident

Exclusion Criteria:

  • The PTSD consecutive to several traumatic events
  • Patients treated by a substance crossing the blood-brain barrier (with the exception of the antidepressants of the family of the ISRS which can be indicated in the treatment of PTSD)
  • Histories of epilepsy or significant loss of consciousness of any origin, including post-traumatic
  • Any psychiatric or somatic significant pathology
  • The psychiatric histories in particular of suicide attempt
  • The pregnant or breast-feeding women
  • Contraindications in the propanolol
  • Consumption of psychoactive drugs detected in urines
  • Excessive alcohol consumption
  • The persons not being capable of understanding or of reading the information describing the study
  • The patients refusing to sign the form of consent of participation for the study
  • The left-handed or ambidextrous patients
  • The patients without the general regime of the health insurance
  • The patients under guardianship or incapable major
  • The patients who will not be capable of supplying a documentary evidence of identity the day of the inclusion
  • Contraindication in the practice of a MRI
  • The patients or the controls refusing the medical and psychiatric balance assessment of screening cannot participate in the study
  • Strong probability of not compliance to the protocol or of abandonment in the course of study
  • Taking of a speechless medicine, in particular beta-blocking
  • Participating in phase of exclusion from a previous study
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01239173
AOM06075/ P060226
Yes
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Charles-Siegfried Peretti, MD, PhD Saint-Antoine hospital, Psychiatry unit, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Assistance Publique - Hôpitaux de Paris
February 2012

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