NCT01713556

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

4.5 years

First QC Date

October 22, 2012

Last Update Submit

September 21, 2026

Conditions

Post-traumatic Stress Disorder

Keywords

PTSD, Propranolol

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

EXPERIMENTAL

they have a script-driven mental imagery of the traumatic event white drug

Drug: PropranololOther: Trauma reactivation

Placebo + reactivation

PLACEBO COMPARATOR

They have a script-driven mental imagery of the traumatic event with placebo

Other: Trauma reactivationDrug: placebo

Interventions

PropranololDRUG
Propranolol + reactivation
Trauma reactivationOTHER

Trauma reactivation: script-driven mental imagery of the traumatic event

Placebo + reactivationPropranolol + reactivation
placeboDRUG
Placebo + reactivation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Chru Lille

Lille, 59037, France

Location

Chu Montpellier

Montpellier, 34295, France

Location

CHU Toulouse

Toulouse, 31000, France

Location

Related Publications (4)

  • Very E, Leroy A, Richaud L, Vaiva G, Jardri R, Roullet P, Taib S, Bourcier A, Loubinoux I, Birmes P. Hippocampal connectivity changes after traumatic memory reactivation with propranolol for posttraumatic stress disorder: a randomized fMRI study. Eur J Psychotraumatol. 2025 Dec;16(1):2466886. doi: 10.1080/20008066.2025.2466886. Epub 2025 Apr 22.

    PMID: 40261001RESULT

  • Roullet P, Taib S, Thalamas C, Vaiva G, El Hage W, Yrondi A, Birmes P. Efficacy of traumatic memory reactivation with or without propranolol in PTSD with high dissociative experiences. Eur J Psychotraumatol. 2022 Dec;13(2):2151098. doi: 10.1080/20008066.2022.2151098. Epub 2022 Dec 1.

    PMID: 38872596RESULT

  • 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: 33612830RESULT

  • Leroy A, Very E, Birmes P, Yger P, Szaffarczyk S, Lopes R, Outteryck O, Faure C, Duhem S, Grandgenevre P, Warembourg F, Vaiva G, Jardri R. Intrusive experiences in posttraumatic stress disorder: Treatment response induces changes in the directed functional connectivity of the anterior insula. Neuroimage Clin. 2022;34:102964. doi: 10.1016/j.nicl.2022.102964. Epub 2022 Feb 10.

    PMID: 35189456RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Philippe BIRMES, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

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

September 25, 2026

Record last verified: 2026-09

Locations

FR(4)