NCT00465608

Brief Summary

Problem and Objectives: There is currently no pharmacological treatment for curing post traumatic stress disorder (PTSD). The investigators will test whether propranolol when given immediately after trauma evocation is able to decrease the strength of the traumatic memory, and by extension, the severity of PTSD symptoms associated with that memory. Hypotheses:

  1. 1.The subjects will show a significant pre/post decrease in PTSD symptoms.
  2. 2.Those gains will be maintained at follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

January 7, 2009

Status Verified

January 1, 2009

Enrollment Period

1.6 years

First QC Date

April 24, 2007

Last Update Submit

January 6, 2009

Conditions

Post-Traumatic Stress Disorder

Keywords

adultsPTSDtraumaAZFpropranololreconsolidationPost traumatic stress disorderchronic formPTSD (Post-Traumatic Stress Disorder)

Outcome Measures

Primary Outcomes (1)

  • PTSD Checklist score

    3 months

Secondary Outcomes (1)

  • SCID diagnosis

    3 months

Study Arms (1)

1

EXPERIMENTAL

propranolol

Drug: propranolol

Interventions

propranololDRUG

propranolol by mouth (per os)

Also known as: betablocker
1

Eligibility Criteria

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

You may qualify if:

  • years old
  • Suffer from AZF-related PTSD (PCL score more than 44)
  • Sign consent form
  • Subjects must have health coverage.

You may not qualify if:

  • Not diagnosed with current, chronic AZF-related PTSD
  • Age \< 18 or \> 65
  • Systolic blood pressure \< 100 mm Hg
  • occurred within the past ten years,
  • occurred at any time in life if induced by a β-blocker, or
  • are currently being treated, regardless of the date of last occurrence.
  • Cardiological consultation will be obtained as necessary.
  • Previous adverse reaction to, or non-compliance with, a β-blocker
  • Current use of medication that may involve potentially dangerous interactions with propranolol, including, other β-blockers, antiarrhythmics, calcium channel blockers, and potent P450 2D6 inhibitors, e.g., fluoxetine, paroxetine, miconazole, sulconazole, metoclopramide, quinidine, ticlopidine, and ritonavir.
  • Contraindicating psychiatric condition, including lifetime or current psychotic, bipolar, melancholic, or substance dependence or abuse disorder; suicidality.
  • Initiation of, or change in, psychotropic medication within the previous two months. For subjects receiving stable doses of pharmacotherapy, they and their providers will be asked not to change the regimen except in clinically urgent circumstances; if this becomes necessary, a decision will be made on a case-by-case basis with regard to retaining the subject or terminating participation.
  • Current participation in any psychotherapy (other than strictly supportive). Subjects will be asked not to initiate psychotherapy during the course of the proposed study except in clinically urgent circumstances; if this becomes necessary, a decision will be made on a case-by-case basis with regard to retaining the subject or terminating participation.
  • Inability to understand the study's procedures, risks, and side effects, or to otherwise give informed consent for participation
  • Does not understand French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Department

Toulouse, 31059, France

Location

Related Publications (2)

  • Pitman RK, Sanders KM, Zusman RM, Healy AR, Cheema F, Lasko NB, Cahill L, Orr SP. Pilot study of secondary prevention of posttraumatic stress disorder with propranolol. Biol Psychiatry. 2002 Jan 15;51(2):189-92. doi: 10.1016/s0006-3223(01)01279-3.

    PMID: 11822998BACKGROUND

  • Vaiva G, Ducrocq F, Jezequel K, Averland B, Lestavel P, Brunet A, Marmar CR. Immediate treatment with propranolol decreases posttraumatic stress disorder two months after trauma. Biol Psychiatry. 2003 Nov 1;54(9):947-9. doi: 10.1016/s0006-3223(03)00412-8.

    PMID: 14573324BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and InjuriesCombat Disorders

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

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2007

First Posted

April 25, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

January 7, 2009

Record last verified: 2009-01

Locations

FR(1)