Using Reconsolidation Blockade to Treat Trauma Related Disorders After Paris Attacks: an Effectiveness Study
PARIS-MEM
2 other identifiers
interventional
364
2 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2016
Typical duration for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2016
CompletedStudy Start
First participant enrolled
May 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedMarch 22, 2023
March 1, 2023
3.6 years
May 20, 2016
March 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Reconsolidation blockade
EXPERIMENTALβ-adrenergic blocker propranolol 1 mg / kg to each of the 6 treatment sessions
Treatment as usual
ACTIVE COMPARATORTreatment as usual like SSRIs, psychotherapy, ...
Interventions
Eligibility Criteria
You may qualify if:
- Age 16 years or older
- Suffer from PTSD, adjustment disorders or other specified trauma- and stressor-related disorder
- PTSD Checklist - Specific (PCL-S) \> 44
- Clinical Global Impression (CGI) \> 3
- Informed Consent Form signed
- Fluency in French
You may not qualify if:
- Reconsolidation blockade group:
- Resting systolic blood pressure \< 100 mm Hg
- Resting heart rate \< 55 beats per minute
- EKG significantly abnormal
- Medical contraindication to use propranolol
- Current use of medication that involve potentially dangerous interactions with propranolol
- Previous adverse reaction to a β-adrenergic blocker
- Current use of a β-adrenergic blocker
- Patients taking psychotropic drugs which may interact with propranolol will be examined on a case-by-case basis
- Both groups:
- Subject under legal protection
- Bipolar or psychotic disorder
- Head trauma for less than one year or with clinical symptoms and neurological sequelae
- Proven severe suicide risk (Mini-S and clinical assessment)
- Opioid addiction or current alcohol dependence
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- MSD Francecollaborator
Study Sites (20)
Hôpital Albert Chenevier
Créteil, 94010, France
Hôpital Henri Mondor
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
Related Publications (2)
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.
PMID: 35404227DERIVEDBrunet 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.
PMID: 31703570DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno MILLET, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2016
First Posted
June 3, 2016
Study Start
May 27, 2016
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
March 22, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
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.