NCT Number: NCT02789982
Using Reconsolidation Blockade to Treat Trauma Related Disorders After Paris Attacks: an Effectiveness 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.
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Notify MeKey information
Conditions
Age range
16 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Hôpital Albert Chenevier, Créteil, France
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Treatment as Usual
BehavioralPrimary outcomes
-
The PTSD Checklist (PCL-S)
Time frame: change from baseline to 12 months follow-up
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)
-
Medical resources use
Time frame: from baseline to 12 months follow-up
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
-
Quality of life assessed by EQ-5D-5L Euroquol questionnaire
Time frame: at 12- months follow-up
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)
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Collaborators
- MSD France
Registry information
Acronym: PARIS-MEM
Important dates
- Study start
- 2016
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Jun 3, 2016
- Registry last updated
- Mar 22, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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