Propranolol in Post Traumatic Stress Disorder (Reductrauma)
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|ClinicalTrials.gov Identifier: NCT00465608|
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : January 7, 2009
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorder||Drug: propranolol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduction of the Traumatic Memory by Reconsolidation Blockade: A Pilot Study|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
propranolol by mouth (per os)
Other Name: betablocker
- PTSD Checklist score [ Time Frame: 3 months ]
- SCID diagnosis [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465608
|Toulouse, France, 31059|
|Principal Investigator:||Philippe BIRMES||University Hospital, Toulouse|