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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-27

Study Completion Date

2019-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-traumatic Stress Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reconsolidation blockade

β-adrenergic blocker propranolol 1 mg / kg to each of the 6 treatment sessions

Group Type EXPERIMENTAL

β-adrenergic blocker propranolol

Intervention Type DRUG

Treatment as usual

Treatment as usual like SSRIs, psychotherapy, ...

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Interventions

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β-adrenergic blocker propranolol

Intervention Type DRUG

Treatment as usual

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No