Ignite Creation Date:
2024-05-06 @ 8:38 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02789982
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2016-05-20
Brief Title:
Using Reconsolidation Blockade to Treat Trauma Related Disorders After Paris Attacks an Effectiveness Study
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Using Reconsolidation Blockade to Treat Trauma Related Disorders After Paris Attacks an Effectiveness Study
Status:
COMPLETED
Status Verified Date:
2023-03
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:
PARIS-MEM
Brief Summary:
The purpose of this study is 1 to examine the effectiveness of reconsolidation blockade as a treatment for trauma-related disorders 2 to evaluate the feasibility of implementing this new treatment on a large scale in a short delay This clinical trial as been set up in response to the Paris attacks to increase treatment capacity of the AP-HP Assistance Publique des Hopitaux de Paris hospital network Reconsolidation blockade will be compared to treatment as usual TAU on symptoms reduction after 6 weeks of treatment In order to measure effectiveness and cost-utility socioeconomic measures quality of life and social functioning outcomes will be measured pre- and post-treatment as well as 3 and 12 months after study enrollment
Detailed Description:
The November 13th Paris attacks were the most violent and devastating events to occur in France since World War II A large number of persons are likely to develop PTSD or trauma-related disorders especially victims directly involved their families as well as the the first responders In this context there is an urgent need to enhance treatment resources Psychotherapy is known to be effective but it is costly and require qualified professionals Pharmacotherapy eg selective serotonin reuptake inhibitorSSRIs is also considered effective However side effects often lead patients to abandon their treatment An alternative evidence-based intervention is the use of the β-adrenergic blocker propranolol used to interfere with the reconsolidation of a recalled traumatic memory so as to reduce its strength over time This clinical trial will evaluate the effectiveness and cost-utility of reconsolidation blockade compared to treatment as usual The study involves four assessments pre- and post-treatment and 13 weeks and 1 year follow up The outcome measures include PTSD symptoms socioeconomic variables quality of life and social functioning measures The investigators hypothesize that all patients will improve However patients receiving reconsolidation blockade will recover faster than treatment as usual Finally investigators hypothesize that reconsolidation blockade will be well accepted both by the professionals and the patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-000257-12 | EUDRACT_NUMBER | None | None |