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| Sponsor: | University Hospital, Toulouse |
|---|---|
| Information provided by: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT00465608 |
Purpose
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:
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Traumatic Stress Disorder |
Drug: propranolol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Reduction of the Traumatic Memory by Reconsolidation Blockade: A Pilot Study |
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
propranolol
|
Drug: propranolol
propranolol by mouth (per os)
Other Name: betablocker
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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:
Cardiological consultation will be obtained as necessary.
Contacts and Locations
More Information
| Responsible Party: | M.E. Llau, UHToulouse |
| ClinicalTrials.gov Identifier: | NCT00465608 History of Changes |
| Other Study ID Numbers: | 0604603 |
| Study First Received: | April 24, 2007 |
| Last Updated: | January 6, 2009 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
adults PTSD trauma AZF propranolol |
reconsolidation Post traumatic stress disorder chronic form PTSD (Post-Traumatic Stress Disorder) |
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Propranolol Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Antihypertensive Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasodilator Agents |