Emotional Memory Reactivation in Posttraumatic Stress Disorder (VIVITRAU)

July 25, 2012 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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 This seems to be confirmed by an as yet unpublished human based study that suggests that propranolol may impair reconsolidation of conditioned fear-response (Miller et al., 2004) The primary purpose of our study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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75012
        • Saint-Antoine Hospital, Psychiatriy unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Placebo Comparator: 2
Post-traumatic stress disorder receiving placebo 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: 3
Controls receiving propanolol 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
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
Placebo Comparator: 4
Controls receiving placebo 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
34 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of propranolol therapeutic effects versus placebo on symptom provocation state in traumatized subjects with and without posttraumatic stress disorder
Time Frame: 34 days
34 days
Comparison of activated neuronal networks when a patient remember a pleasant , unpleasant or traumatic event
Time Frame: 34 days
34 days
Comparison of emotional status of traumatized subjects with and without posttraumatic stress disorder
Time Frame: 34 days
34 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Charles-Siegfried Peretti, MD, PhD, Saint-Antoine hospital, Psychiatry unit, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM06075/ P060226

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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