Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial (REDUCTRAUMA2)
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Purpose
The purpose of this study is to test whether propranolol, when given during a re-evocation of a traumatic memory, is capable of reducing subsequent PTSD symptoms associated with that memory.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-traumatic Stress Disorder |
Drug: Propranolol Other: Trauma reactivation Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial |
- PTCD CheckList (PCL) total score. [ Time Frame: difference between week 1 (before administration of the study medication) and week 7 (one week after the last intake of study medication) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Propranolol + reactivation
they have a script-driven mental imagery of the traumatic event white drug
|
Drug: Propranolol
Other: Trauma reactivation
Trauma reactivation: script-driven mental imagery of the traumatic event
|
|
Placebo Comparator: Placebo + reactivation
They have a script-driven mental imagery of the traumatic event with placebo
|
Other: Trauma reactivation
Trauma reactivation: script-driven mental imagery of the traumatic event
Drug: placebo
|
Detailed Description:
Post-traumatic stress disorder (PTSD) develops following an exposure to a life threatening event. One of the characteristic features of PTSD is the recurrence of intrusive memories of an experienced trauma. The persistence of disturbing traumatic memories in PTSD is often explained in terms of a trauma-induced enhancement of memory encoding. Several studies indicate that an increased noradrenergic activity during trauma enhances the encoding of memory. Elevated levels of norepinephrine in the cerebrospinal fluid of individuals with PTSD and the correlation of this elevation with the severity of PTSD symptoms suggest that increased noradrenergic activity is also involved in the maintenance of PTSD symptoms. Reactivation of memory by retrieval also renders the memory labile and susceptible to treatments. This latter process is referred to as memory reconsolidation. Consolidation and reconsolidation both occur within a distinct time window following new learning (in consolidation) and/or retrieval (in reconsolidation). Even well-consolidated old fear memories undergo reconsolidation and may be disrupted by means of pharmacological manipulation. Propranolol may be effective in treating PTSD long after symptoms have been consolidated. Propranolol given after reactivation of the memory of a past traumatic event reduces physiologic responding during subsequent mental imagery of the event.
HYPOTHESE: Subjects with chronic PTSD who receive propranolol before trauma evocation will subsequently show decreased PTSD symptoms, compared to subjects who receive a placebo.
METHOD: 56 participants with chronic PTSD will be recruited for participation. On Week 1, the subjects will complete a standardized measure of PTSD symptoms. Next, 90 minutes after the administration of the study medication (either propranolol or placebo), participants will undergo a script preparation procedure, during which they will disclose details of their traumatic event. Scripts portraying this event will be prepared for subsequent replay.
On Week 2, after the administration of the study medication (either propranolol or placebo), participants will be asked (reading the script) to engaged in a script-driven mental imagery of the traumatic event. Following this procedure, PTSD symptoms will be assessed.
The same procedure will be repeated on Weeks 3, 4, 5 and 6. On Weeks 7 and 18, the standardized measure of PTSD symptoms will be repeated.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ages 18-65 years
- Diagnosis of chronic PTSD
- PTSD CheckList total score >44
Exclusion Criteria:
- Systolic blood pressure < 100 mmHg
- Contraindication to Propranolol
- Previous adverse reaction to a β-blocker
- Use of another β-blocker
- Use of medication that could involve potentially dangerous interactions with propranolol
- Psychotherapy or treatment with any pharmacologic PTSD medication within the 2 weeks prior to inclusion (6 weeks for fluoxetine)
- Female with reproductive potential without reliable means of contraception
- Pregnancy or lactation
- Alcohol or drug abuse
Contacts and Locations| France | |
| Centre Hospitalier Charles Perrens | Not yet recruiting |
| Bordeaux, France, 33076 | |
| Contact: Bruno AOUIZERATE, PHD 05-56-56-35-85 bruno.aouizerate@u-bordeaux2.fr | |
| Principal Investigator: bruno AOUZERATE, PHD | |
| Chru Lille | Not yet recruiting |
| Lille, France, 59037 | |
| Contact: Guillaume VAIVA, PHD 03.20.44.43.83 gvaiva@chru-lille.fr | |
| Principal Investigator: Guillaume VAIVA, PHD | |
| Chu Montpellier | Not yet recruiting |
| Montpellier, France, 34295 | |
| Contact: Jérôme ATTAL, PHD 04 67 33 97 18 j-attal@chu-montpellier.fr | |
| Principal Investigator: jerome ATTAL, PHD | |
| CHU Toulouse | Recruiting |
| Toulouse, France, 31000 | |
| Contact: Philippe BIRMES, PHD 05 61 77 25 81 birmes.p@chu-toulouse.fr | |
| Principal Investigator: Philippe BIRMES, PHD | |
More Information
No publications provided
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT01713556 History of Changes |
| Other Study ID Numbers: | 09 106 01 |
| Study First Received: | October 22, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | France: L’Agence nationale de sécurité du médicament et des produits de santé |
Keywords provided by University Hospital, Toulouse:
|
PTSD, Propranolol |
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