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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000257-12 | EudraCT Number |
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| Name | Class |
|---|---|
| MSD France | INDUSTRY |
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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.
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 (e.g., selective serotonin reuptake inhibitor,SSRIs) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reconsolidation blockade | Experimental | β-adrenergic blocker propranolol 1 mg / kg to each of the 6 treatment sessions |
|
| Treatment as usual | Active Comparator | Treatment as usual like SSRIs, psychotherapy, ... |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| β-adrenergic blocker propranolol | Drug |
| ||
| Treatment as usual |
| Measure | Description | Time Frame |
|---|---|---|
| The PTSD Checklist (PCL-S) | The PCL-S is a 17-item self-report scale assessing DSM-IV-TR PTSD symptoms in the past week from the perspective of the patient. The PSL-S range between 17 (no symptom) and 85 (maximum score) | change from baseline to 12 months follow-up |
| Medical resources use | Costs, in Euros, related to healthcare utilization and work status are evaluated with the MEDico-Economic Questionnaire (MEDEC) adapted from the Client Service Receipt Inventory in order to meet the specificity of the French Health system | from baseline to 12 months follow-up |
| Quality of life assessed by EQ-5D-5L Euroquol questionnaire | The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated on five levels of severity. The levels of severity for each dimension ranges from no problems (1) to extreme problems/unable to perform (0) | at 12- months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
Reconsolidation blockade group:
Both groups:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno MILLET, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Albert Chenevier | Créteil | 94010 | France | |||
| Hôpital Henri Mondor |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35404227 | Derived | Mallet C, Chick CF, Maatoug R, Fossati P, Brunet A, Millet B. Memory reconsolidation impairment using the beta-adrenergic receptor blocker propranolol reduces nightmare severity in patients with posttraumatic stress disorder: a preliminary study. J Clin Sleep Med. 2022 Jul 1;18(7):1847-1855. doi: 10.5664/jcsm.10010. | |
| 31703570 | Derived |
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Data are available upon reasonable request :
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| Behavioral |
|
| Créteil |
| 94010 |
| France |
| Hôpital Raymond Poincaré | Garches | 92380 | France |
| Hôpital Corentin Celton | Issy-les-Moulineaux | 92130 | France |
| Grand Hôpital EST FRANCILIEN - site de Marne-la-Vallée | Jossigny | 77600 | France |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
| CHRU et CIC de LILLE | Lille | 59037 | France |
| Grand Hôpital EST FRANCILIEN - site de Meaux | Meaux | 77100 | France |
| Chu Pasteur | Nice | 06001 | France |
| Centre Hospitalier Sainte Marie | Nice | 06009 | France |
| Hôpital Maison Blanche Hauteville | Paris | 75010 | France |
| Hôpital Saint Antoine | Paris | 75012 | France |
| Groupe Hospitalier Pitié-Salpêtrière | Paris | 75013 | France |
| Hôpital Tenon | Paris | 75020 | France |
| Hôpital Sainte-Anne | Paris | 75674 | France |
| Centre Hospitalier Henri Laborit | Poitiers | 86021 | France |
| EPS Ville Evrard - site de Saint Denis | Saint-Denis | 93000 | France |
| Hôpitaux de Saint Maurice | Saint-Maurice | 94410 | France |
| Centre Hospitalier du Rouvray | Sotteville-lès-Rouen | 76301 | France |
| Centre Hospitalier Universitaire de Martinique | Fort-de-France | 97261 | Martinique |
| Brunet A, Ayrolles A, Gambotti L, Maatoug R, Estellat C, Descamps M, Girault N, Kalalou K, Abgrall G, Ducrocq F, Vaiva G, Jaafari N, Krebs MO, Castaigne E, Hanafy I, Benoit M, Mouchabac S, Cabie MC, Guillin O, Hodeib F, Durand-Zaleski I, Millet B. Paris MEM: a study protocol for an effectiveness and efficiency trial on the treatment of traumatic stress in France after the 2015-16 terrorist attacks. BMC Psychiatry. 2019 Nov 8;19(1):351. doi: 10.1186/s12888-019-2283-4. |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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