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

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ClinicalTrials.gov Identifier: NCT01713556
Recruitment Status : Unknown
Verified February 2017 by University Hospital, Toulouse.
Recruitment status was:  Recruiting
First Posted : October 24, 2012
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE October 22, 2012
First Posted Date  ICMJE October 24, 2012
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01713556 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial
Official Title  ICMJE Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post-traumatic Stress Disorder
Intervention  ICMJE
  • Drug: Propranolol
  • Other: Trauma reactivation
    Trauma reactivation: script-driven mental imagery of the traumatic event
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: Propranolol + reactivation
    they have a script-driven mental imagery of the traumatic event white drug
    Interventions:
    • Drug: Propranolol
    • Other: Trauma reactivation
  • Placebo Comparator: Placebo + reactivation
    They have a script-driven mental imagery of the traumatic event with placebo
    Interventions:
    • Other: Trauma reactivation
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 22, 2012)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01713556
Other Study ID Numbers  ICMJE 09 106 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe BIRMES, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP