Treatment of PTSD by Reduction of Traumatic Memory Reconsolidation by Propranolol : a Multisite Trial
REDUCTRAUMA2
1 other identifier
interventional
87
1 country
4
Brief Summary
The purpose of this study is to test whether propranolol, when given during a re-evocation of a traumatic memory, is capable of reducing subsequent PTSD symptoms associated with that memory.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2012
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 24, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedNovember 9, 2020
November 1, 2020
4.5 years
October 22, 2012
November 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PTCD CheckList (PCL) total score.
difference between week 1 (before administration of the study medication) and week 7 (one week after the last intake of study medication)
Study Arms (2)
Propranolol + reactivation
EXPERIMENTALthey have a script-driven mental imagery of the traumatic event white drug
Placebo + reactivation
PLACEBO COMPARATORThey have a script-driven mental imagery of the traumatic event with placebo
Interventions
Trauma reactivation: script-driven mental imagery of the traumatic event
Eligibility Criteria
You may qualify if:
- Diagnosis of chronic PTSD
- PTSD CheckList total score \>44
You may not qualify if:
- Systolic blood pressure \< 100 mmHg
- Contraindication to Propranolol
- Previous adverse reaction to a β-blocker
- Use of another β-blocker
- Use of medication that could involve potentially dangerous interactions with propranolol
- Female with reproductive potential without reliable means of contraception
- Pregnancy or lactation
- Alcohol or drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Centre Hospitalier Charles Perrens
Bordeaux, 33076, France
Chru Lille
Lille, 59037, France
Chu Montpellier
Montpellier, 34295, France
CHU Toulouse
Toulouse, 31000, France
Related Publications (1)
Roullet P, Vaiva G, Very E, Bourcier A, Yrondi A, Dupuch L, Lamy P, Thalamas C, Jasse L, El Hage W, Birmes P. Traumatic memory reactivation with or without propranolol for PTSD and comorbid MD symptoms: a randomised clinical trial. Neuropsychopharmacology. 2021 Aug;46(9):1643-1649. doi: 10.1038/s41386-021-00984-w. Epub 2021 Feb 21.
PMID: 33612830DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe BIRMES, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2012
First Posted
October 24, 2012
Study Start
November 1, 2012
Primary Completion
May 1, 2017
Study Completion
June 30, 2017
Last Updated
November 9, 2020
Record last verified: 2020-11