Propranolol in Post Traumatic Stress Disorder (Reductrauma)

January 6, 2009 updated by: University Hospital, Toulouse

Reduction of the Traumatic Memory by Reconsolidation Blockade: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Psychiatric Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
propranolol
Drug: propranolol
propranolol by mouth (per os)
Other Names:
  • betablocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PTSD Checklist score
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
SCID diagnosis
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Philippe BIRMES, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

April 24, 2007

First Submitted That Met QC Criteria

April 24, 2007

First Posted (Estimate)

April 25, 2007

Study Record Updates

Last Update Posted (Estimate)

January 7, 2009

Last Update Submitted That Met QC Criteria

January 6, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0604603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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