Text Size

Emotional Memory Reactivation in Posttraumatic Stress Disorder (VIVITRAU)

This study has been terminated.
(Study stopped by promoter for lack of inclusion)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01239173
First received: October 25, 2010
Last updated: July 25, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorder
 Drug: AVLOCARDYL
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reliving the Traumatic Event in Posttraumatic Stress Disorder: An Emotional Memory Reactivation Pathology? An fMRI Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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 [ Time Frame: 34 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of propranolol therapeutic effects versus placebo on symptom provocation state in traumatized subjects with and without posttraumatic stress disorder [ Time Frame: 34 days ] [ Designated as safety issue: No ]
  • Comparison of activated neuronal networks when a patient remember a pleasant , unpleasant or traumatic event [ Time Frame: 34 days ] [ Designated as safety issue: No ]
  • Comparison of emotional status of traumatized subjects with and without posttraumatic stress disorder [ Time Frame: 34 days ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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
 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
Other Name: Placebo
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
Other Name: AVLOCARDYL
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
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239173

Locations
France
Saint-Antoine Hospital, Psychiatriy unit
Paris, Ile de France, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Charles-Siegfried Peretti, MD, PhD Saint-Antoine hospital, Psychiatry unit, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01239173     History of Changes
Other Study ID Numbers: AOM06075/ P060226
Study First Received: October 25, 2010
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Posttraumatic stress disorder
functional Magnetic Resonance Imaging
Amygdala
emotion regulation
memory

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013