Using Reconsolidation Blockade to Treat Trauma Related Disorders After Paris Attacks: an Effectiveness Study (PARIS-MEM)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Post-traumatic Stress Disorder

Treatments

Behavioral: Treatment as usual

Drug: β-adrenergic blocker propranolol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02789982

P151201

2016-000257-12 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

364 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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 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
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