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Post-traumatic Stress DisorderPhase 3PARIS-MEMNCT02789982

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

A Phase 3 study testing β-adrenergic blocker propranolol and Treatment as usual in people with Post-traumatic Stress Disorder, run by Assistance Publique - Hôpitaux de Paris at 20 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Post-traumatic Stress Disorder
What is being tested?
β-adrenergic blocker propranolol and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
364 participants
Where
20 sitesin 2 countries
Study dates
27 May 2016to 30 Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

France19 sites

  • Hôpital Albert Chenevier

    Créteil, 94010

  • Hôpital Henri Mondor

    Créteil, 94010

  • Hôpital Raymond Poincaré

    Garches, 92380

  • Hôpital Corentin Celton

    Issy-les-Moulineaux, 92130

  • Grand Hôpital EST FRANCILIEN - site de Marne-la-Vallée

    Jossigny, 77600

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270

  • CHRU et CIC de LILLE

    Lille, 59037

  • Grand Hôpital EST FRANCILIEN - site de Meaux

    Meaux, 77100

  • Chu Pasteur

    Nice, 06001

  • Centre Hospitalier Sainte Marie

    Nice, 06009

  • Hôpital Maison Blanche Hauteville

    Paris, 75010

  • Hôpital Saint Antoine

    Paris, 75012

  • Groupe Hospitalier Pitié-Salpêtrière

    Paris, 75013

  • Hôpital Tenon

    Paris, 75020

  • Hôpital Sainte-Anne

    Paris, 75674

  • Centre Hospitalier Henri Laborit

    Poitiers, 86021

  • EPS Ville Evrard - site de Saint Denis

    Saint-Denis, 93000

  • Hôpitaux de Saint Maurice

    Saint-Maurice, 94410

  • Centre Hospitalier du Rouvray

    Sotteville-lès-Rouen, 76301

Other trials in France

Martinique1 site

  • Centre Hospitalier Universitaire de Martinique

    Fort-de-France, 97261

Other trials in Martinique

About this study

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.

Read the detailed 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.

Being tested
β-adrenergic blocker propranolol, Treatment as usual
Keywords
PTSD, Trauma related disorders, Reconsolidation blockade, Paris attacks
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02789982
Study groupRoleWhat they receive
Reconsolidation blockadeExperimentalβ-adrenergic blocker propranolol 1 mg / kg to each of the 6 treatment sessions
Receives: Drug: β-adrenergic blocker propranolol
Treatment as usualActive comparatorTreatment as usual like SSRIs, psychotherapy, ...
Receives: Behavioral: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: change from baseline to 12 months follow-up

  2. 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

    Measured: from baseline to 12 months follow-up

  3. 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)

    Measured: at 12- months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2016 (estimated)
  2. Study start27 May 2016
  3. Primary completion30 Dec 2019
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
364 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02789982
Sponsor's protocol ID
P151201
Other IDs
2016-000257-12, 2016
Acronym
PARIS-MEM
Status last verified
Mar 2023
First submitted
20 May 2016
Last updated
22 Mar 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 35404227

  • 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.

    PubMed 31703570

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing β-adrenergic blocker propranolol and Treatment as usual in people with Post-traumatic Stress Disorder, run by Assistance Publique - Hôpitaux de Paris at 20 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The PTSD Checklist (PCL-S) (time frame: change from baseline to 12 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02789982, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.

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