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

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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-effectiveness, 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Adrenergic Agents; Adrenergic Antagonists; Propranolol

Criteria

Inclusion Criteria:

• Age 18 years or older

• Fluency in French

• Suffer from PTSD, adjustment disorders or other specified trauma- and stressor-related disorder

• PTSD Checklist - Specific (PCL-S) > 44

• Clinical Global Impression (CGI) > 3

Exclusion Criteria:

Reconsolidation blockade group:

• Resting heart rate < 55 beats per minute

• Resting systolic blood pressure < 100 mm Hg

• A history of congestive heart failure, hypoglycemic medication-requiring diabetes, chronic bronchitis or asthma.

• Brain injury

• Previous adverse reaction to a β-adrenergic blocker

• Current use of a β-adrenergic blocker

• Current use of medication that involve potentially dangerous interactions with propranolol

Both groups:

• Current pregnancy (Positive pregnancy test) or breast-feeding

• Currently suicidal or homicidal

• Contraindicating neuropsychiatric condition, e.g., current psychotic, bipolar, or substance dependence or abuse disorder

• Patients using SSRI for less than 2 months