Status:
COMPLETED
Propranolol in Post Traumatic Stress Disorder
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 18-65 years old
- Suffer from AZF-related PTSD (PCL score more than 44)
- Sign consent form
- Subjects must have health coverage.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00465608
Start Date
April 1 2007
End Date
November 1 2008
Last Update
January 7 2009
Active Locations (1)
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1
Psychiatric Department
Toulouse, France, 31059