Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465608
Status:
COMPLETED
Last Update Posted:
2009-01-07
First Post:
2007-04-24
Brief Title:
Propranolol in Post Traumatic Stress Disorder
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Reduction of the Traumatic Memory by Reconsolidation Blockade A Pilot Study
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Reductrauma
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
1 The subjects will show a significant prepost 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 Fishers 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
Hypotheses
1 The subjects will show a significant prepost 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 Fishers 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None