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Propranolol in Post Traumatic Stress Disorder (Reductrauma)

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
propranolol
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring adults, PTSD, trauma, AZF, propranolol, reconsolidation, Post traumatic stress disorder, chronic form, PTSD (Post-Traumatic Stress Disorder)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatric Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

propranolol

Outcomes

Primary Outcome Measures

PTSD Checklist score

Secondary Outcome Measures

SCID diagnosis

Full Information

First Posted
April 24, 2007
Last Updated
January 6, 2009
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT00465608
Brief Title
Propranolol in Post Traumatic Stress Disorder
Acronym
Reductrauma
Official Title
Reduction of the Traumatic Memory by Reconsolidation Blockade: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: The subjects will show a significant pre/post decrease in PTSD symptoms. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
adults, PTSD, trauma, AZF, propranolol, reconsolidation, Post traumatic stress disorder, chronic form, PTSD (Post-Traumatic Stress Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
propranolol
Intervention Type
Drug
Intervention Name(s)
propranolol
Other Intervention Name(s)
betablocker
Intervention Description
propranolol by mouth (per os)
Primary Outcome Measure Information:
Title
PTSD Checklist score
Time Frame
3 months
Secondary Outcome Measure Information:
Title
SCID diagnosis
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe BIRMES
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Department
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
11822998
Citation
Pitman RK, Sanders KM, Zusman RM, Healy AR, Cheema F, Lasko NB, Cahill L, Orr SP. Pilot study of secondary prevention of posttraumatic stress disorder with propranolol. Biol Psychiatry. 2002 Jan 15;51(2):189-92. doi: 10.1016/s0006-3223(01)01279-3.
Results Reference
background
PubMed Identifier
14573324
Citation
Vaiva G, Ducrocq F, Jezequel K, Averland B, Lestavel P, Brunet A, Marmar CR. Immediate treatment with propranolol decreases posttraumatic stress disorder two months after trauma. Biol Psychiatry. 2003 Nov 1;54(9):947-9. doi: 10.1016/s0006-3223(03)00412-8. Erratum In: Biol Psychiatry. 2003 Dec 15;54(12):1471.
Results Reference
background

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Propranolol in Post Traumatic Stress Disorder

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