Emotional Memory Reactivation in Posttraumatic Stress Disorder
Information source: Assistance Publique - H˘pitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Posttraumatic Stress Disorder
Intervention: AVLOCARDYL (Drug); Placebo (Drug); AVLOCARDYL (Drug); Placebo (Drug)
Phase: Phase 3
Sponsored by: Assistance Publique - H˘pitaux de Paris
Official(s) and/or principal investigator(s):
Charles-Siegfried Peretti, MD, PhD, Principal Investigator, Affiliation: Saint-Antoine hospital, Psychiatry unit, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
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.
Official title: Reliving the Traumatic Event in Posttraumatic Stress Disorder: An Emotional Memory Reactivation Pathology? An fMRI Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Effect of propanolol, a beta adrenergic antagonism, on amygdala activation during a symptom provocation state in traumatized subjects with and without posttraumatic stress disorder
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
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
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.
Minimum age: 18 Years.
Maximum age: 50 Years.
- Patients of French mother language
- Right-handed patients
- Signature of the consent
- Patients whose diagnosis of PTSD according to the criteria of the DSM IV-TR is
- PTSD whose evolution is not chronic
- Established PTSD : Symptoms presents for at least 1 month
- PTSD consecutive to a unique traumatic event
- 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
- Subjects having undergone a traumatism dating less than 3 months
- Examples of traumatic events: aggression, accident of the public highway, the
- 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
- 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
- Taking of a speechless medicine, in particular beta-blocking
- Participating in phase of exclusion from a previous study
Locations and Contacts
Saint-Antoine Hospital, Psychiatriy unit, Paris, Ile de France 75012, France
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Starting date: September 2010
Last updated: July 25, 2012