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Emotional Memory Reactivation in Posttraumatic Stress Disorder (VIVITRAU)

Primary Purpose

Posttraumatic Stress Disorder

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
AVLOCARDYL
Placebo
AVLOCARDYL
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic stress disorder, functional Magnetic Resonance Imaging, Amygdala, emotion regulation, memory

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Saint-Antoine Hospital, Psychiatriy unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Post-traumatic stress disorder patient receiving propanolol 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI

Post-traumatic stress disorder receiving placebo 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI

Controls receiving propanolol 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI

Controls receiving placebo 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI

Outcomes

Primary Outcome Measures

Effect of propanolol, a beta adrenergic antagonism, on amygdala activation during a symptom provocation state in traumatized subjects with and without posttraumatic stress disorder

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2010
Last Updated
July 25, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01239173
Brief Title
Emotional Memory Reactivation in Posttraumatic Stress Disorder
Acronym
VIVITRAU
Official Title
Reliving the Traumatic Event in Posttraumatic Stress Disorder: An Emotional Memory Reactivation Pathology? An fMRI Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
Study stopped by promoter for lack of inclusion
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic stress disorder, functional Magnetic Resonance Imaging, Amygdala, emotion regulation, memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Post-traumatic stress disorder patient receiving propanolol 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Post-traumatic stress disorder receiving placebo 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
Arm Title
3
Arm Type
Active Comparator
Arm Description
Controls receiving propanolol 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Controls receiving placebo 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
Intervention Type
Drug
Intervention Name(s)
AVLOCARDYL
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
AVLOCARDYL
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Comparison of propranolol therapeutic effects versus placebo on symptom provocation state in traumatized subjects with and without posttraumatic stress disorder
Time Frame
34 days
Title
Comparison of activated neuronal networks when a patient remember a pleasant , unpleasant or traumatic event
Time Frame
34 days
Title
Comparison of emotional status of traumatized subjects with and without posttraumatic stress disorder
Time Frame
34 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles-Siegfried Peretti, MD, PhD
Organizational Affiliation
Saint-Antoine hospital, Psychiatry unit, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint-Antoine Hospital, Psychiatriy unit
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

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Emotional Memory Reactivation in Posttraumatic Stress Disorder

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