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Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial (REDUCTRAUMA2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01713556
First received: October 22, 2012
Last updated: July 23, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713556

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         
Sponsors and Collaborators
University Hospital, Toulouse
  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: July 23, 2014
Health Authority: France: 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
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014