Using Reconsolidation Blockade to Treat Trauma Related Disorders After Paris Attacks: an Effectiveness Study

Post-traumatic Stress Disorder Clinical Trial

— PARIS-MEM  

Official title:

Using Reconsolidation Blockade to Treat Trauma Related Disorders After Paris Attacks: an Effectiveness Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789982
• Other study ID #: P151201
• Secondary ID: 2016-000257-12
• Status: Completed
• Phase: Phase 3
• Start date: May 27, 2016
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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 ß-adrenergic blocker

• Current use of a ß-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

• Patients using SSRI for less than 2 months

• Absence of affiliation to National french social security system

• Pregnant or breastfeeding woman or without effective contraception

Related Conditions & MeSH terms

• Disease
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• ß-adrenergic blocker propranolol

Behavioral:
• Treatment as usual

Locations

Country	Name	City	State
France	Hôpital Albert Chenevier	Créteil
France	Hôpital Henri Mondor	Créteil
France	Hôpital Raymond Poincaré	Garches
France	Hôpital Corentin Celton	Issy-les-Moulineaux
France	Grand Hôpital EST FRANCILIEN - site de Marne-la-Vallée	Jossigny
France	Hôpital Bicêtre	Le Kremlin-Bicêtre
France	CHRU et CIC de LILLE	Lille
France	Grand Hôpital EST FRANCILIEN - site de Meaux	Meaux
France	Centre Hospitalier Sainte Marie	Nice
France	Chu Pasteur	Nice
France	Groupe Hospitalier Pitié-Salpêtrière	Paris
France	Hôpital Maison Blanche Hauteville	Paris
France	Hôpital Saint Antoine	Paris
France	Hôpital Sainte-Anne	Paris
France	Hôpital Tenon	Paris
France	Centre Hospitalier Henri Laborit	Poitiers
France	EPS Ville Evrard - site de Saint Denis	Saint-Denis
France	Hôpitaux de Saint Maurice	Saint-Maurice
France	Centre Hospitalier du Rouvray	Sotteville-lès-Rouen
Martinique	Centre Hospitalier Universitaire de Martinique	Fort-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	MSD France

Countries where clinical trial is conducted

France,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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