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Trial record 2 of 2 for:    reductrauma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01713556
Recruitment Status : Completed
First Posted : October 24, 2012
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
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 or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Drug: Propranolol Other: Trauma reactivation Drug: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial
Actual Study Start Date : November 2012
Actual Primary Completion Date : May 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713556


Locations
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France
Centre Hospitalier Charles Perrens
Bordeaux, France, 33076
Chru Lille
Lille, France, 59037
Chu Montpellier
Montpellier, France, 34295
CHU Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Philippe BIRMES, MD University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01713556    
Other Study ID Numbers: 09 106 01
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Keywords provided by University Hospital, Toulouse:
PTSD, Propranolol
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents