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Propranolol in Post Traumatic Stress Disorder (Reductrauma)

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: NCT00465608
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : January 7, 2009
Sponsor:
Information provided by:
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE April 24, 2007
First Posted Date  ICMJE April 25, 2007
Last Update Posted Date January 7, 2009
Study Start Date  ICMJE April 2007
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2007)
PTSD Checklist score [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2007)
PTSD Checklist score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2007)
SCID diagnosis [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2007)
SCID diagnosis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Propranolol in Post Traumatic Stress Disorder
Official Title  ICMJE Reduction of the Traumatic Memory by Reconsolidation Blockade: A Pilot Study
Brief Summary

Problem and Objectives: There is currently no pharmacological treatment for curing post traumatic stress disorder (PTSD). The investigators will test whether propranolol when given immediately after trauma evocation is able to decrease the strength of the traumatic memory, and by extension, the severity of PTSD symptoms associated with that memory.

Hypotheses:

  1. The subjects will show a significant pre/post decrease in PTSD symptoms.
  2. Those gains will be maintained at follow-up.

Study Design: Open pharmacological trial.

Method: On the first visit (V1), the subjects will describe their traumatic experience in writing and will receive the propranolol. A script describing this experience will be constructed to be used in the subsequent encounters to elicit the trauma memory. A week later (V2), before receiving the propranolol, subjects will be asked to read aloud their trauma script while imagining it as vividly as possible for 10 minutes. This weekly treatment will be repeated 6 times (from V1 to V6). A total of 6 doses of propranolol will be given. A self-report measure will be used to monitor improvement in PTSD symptomatology on the following visits: V1, V4, V6, V7 and V8 (3 month follow-up).

Statistical Analyses: A repeated measure ANOVA (pre-test, post-test, and 3-month follow-up) using the PTSD symptom score will be conducted.. Three t-tests will be performed to examine simple effects. The alpha level will be set at p = .05 (two-tailed). Fisher's exact test will be used to examine whether Ss still meet the diagnostic criteria for PTSD at the end of the study.

Clinical Implications: If this treatment is effective, a randomized controlled trial will be launched. This treatment has the potential to become the first pharmacological treatment designed to cure PTSD.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post-Traumatic Stress Disorder
Intervention  ICMJE Drug: propranolol
propranolol by mouth (per os)
Other Name: betablocker
Study Arms  ICMJE Experimental: 1
propranolol
Intervention: Drug: propranolol
Publications *

*   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 Completed
Estimated Enrollment  ICMJE
 (submitted: April 24, 2007)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-65 years old
  • Suffer from AZF-related PTSD (PCL score more than 44)
  • Sign consent form
  • Subjects must have health coverage.

Exclusion Criteria:

  • Not diagnosed with current, chronic AZF-related PTSD
  • Age < 18 or > 65
  • Systolic blood pressure < 100 mm Hg
  • Medical condition that contraindicates the administration of propranolol, e.g., history of congestive heart failure, heart block, insulin-requiring diabetes, chronic bronchitis, emphysema, or asthma. With regard to asthma, because many persons who say they have had an asthma attack, especially as a child, may only have had hay fever, another allergy, or another non-asthmatic episode, a blanket exclusion criterion may be overly restrictive. Therefore, asthma attacks will only be exclusionary if they:

    • occurred within the past ten years,
    • occurred at any time in life if induced by a β-blocker, or
    • are currently being treated, regardless of the date of last occurrence.

Cardiological consultation will be obtained as necessary.

  • Previous adverse reaction to, or non-compliance with, a β-blocker
  • Current use of medication that may involve potentially dangerous interactions with propranolol, including, other β-blockers, antiarrhythmics, calcium channel blockers, and potent P450 2D6 inhibitors, e.g., fluoxetine, paroxetine, miconazole, sulconazole, metoclopramide, quinidine, ticlopidine, and ritonavir.
  • Contraindicating psychiatric condition, including lifetime or current psychotic, bipolar, melancholic, or substance dependence or abuse disorder; suicidality.
  • Initiation of, or change in, psychotropic medication within the previous two months. For subjects receiving stable doses of pharmacotherapy, they and their providers will be asked not to change the regimen except in clinically urgent circumstances; if this becomes necessary, a decision will be made on a case-by-case basis with regard to retaining the subject or terminating participation.
  • Current participation in any psychotherapy (other than strictly supportive). Subjects will be asked not to initiate psychotherapy during the course of the proposed study except in clinically urgent circumstances; if this becomes necessary, a decision will be made on a case-by-case basis with regard to retaining the subject or terminating participation.
  • Inability to understand the study's procedures, risks, and side effects, or to otherwise give informed consent for participation
  • Does not understand French
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 NCT00465608
Other Study ID Numbers  ICMJE 0604603
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.E. Llau, UHToulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe BIRMES University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date January 2009

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