NCT01349439

Brief Summary

The purpose of this study is to test whether propranolol is capable of reducing subsequent physiological trauma-related conditioned responses, as well as self-reported post-traumatic stress disorder (PTSD) symptoms.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

3.8 years

First QC Date

March 31, 2011

Last Update Submit

June 23, 2014

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

  • Electromyogram

    Two weeks post-treatment

  • Heart rate

    Two weeks post-treatment

  • Skin conductance

    Two weeks post-treatment

Secondary Outcomes (4)

  • PTSD symptom levels

    2 to 26 weeks

  • Quality of life

    2 to 26 weeks

  • Memory Experience

    2 to 26 weeks

  • Psychophysiological assessments

    26 weeks

Study Arms (5)

Propranolol + Memory Reactivation

EXPERIMENTAL

This arm involves recalling the traumatic event after administration of propranolol

Drug: Propranolol

Placebo + Memory reactivation

EXPERIMENTAL

This arm involves recalling the traumatic event after administration of a placebo

Drug: Propranolol

Placebo + No Memory Reactivation

EXPERIMENTAL

This arm involves administration of a placebo without recalling the traumatic event

Drug: Propranolol

Propranolol + No Memory Reactivation

EXPERIMENTAL

This arm involves administration of propranolol without recalling the traumatic event

Drug: Propranolol

Open-label Propranolol + Memory Reactivation

OTHER

All participants terminating the double-blind phase of the study will receive open-label reconsolidation blockade treatment with propranolol combined with recall of the traumatic event for six weeks.

Drug: Short acting + long acting propranolol + memory reactivation

Interventions

PropranololDRUG

1mg per Kg (participant weight)

Placebo + Memory reactivationPlacebo + No Memory ReactivationPropranolol + Memory ReactivationPropranolol + No Memory Reactivation
Short acting + long acting propranolol + memory reactivationDRUG

After completing the double-blind phase of the study, participants will receive short acting propranolol 1mg/kg (patient weight) + long acting propranolol (1 or 1.5 mg/kg) followed by memory reactivation. Dose level for the long-acting propranolol will be randomly assigned across participants.

Open-label Propranolol + Memory Reactivation

Eligibility Criteria

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

You may qualify if:

  • Suffer from chronic PTSD for at least 6 consecutive months;
  • Obtain a score of 33 or more on the Impact of Events Scale-Revised:
  • For participants aged 40 years: accept to undergo an electrocardiogram assessment. The results of the electrocardiogram must be normal;
  • Accept to not commence taking new medications on a regular basis during the study.

You may not qualify if:

  • Hypotension;
  • Cardiac rhythm below 55 beats per minute;
  • Medical conditions that contraindicates the administration of propranolol;
  • Previous adverse reaction to, or non-compliance with, beta-blockers;
  • Current use of medication that may involve potentially dangerous interactions with propranolol;
  • Any medication that can have an impact on cardiac rhythm;
  • Women who are breast feeding;
  • Past or present bipolar disorder or psychosis,
  • Present substance abuse or dependence, suicidal ideation;
  • Participating in psychotherapy other than support psychotherapy;
  • An average score above 20 on the Dissociative Experience Scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Douglas Mental Health University Institute

Verdun, Quebec, H4H 1R3, Canada

RECRUITING

Related Publications (1)

  • Brunet A, Orr SP, Tremblay J, Robertson K, Nader K, Pitman RK. Effect of post-retrieval propranolol on psychophysiologic responding during subsequent script-driven traumatic imagery in post-traumatic stress disorder. J Psychiatr Res. 2008 May;42(6):503-6. doi: 10.1016/j.jpsychires.2007.05.006. Epub 2007 Jun 22.

    PMID: 17588604BACKGROUND

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

  • Alain Brunet, Ph.D.

    Douglas Institute Research Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain R Brunet, Ph.D.

CONTACT

514-761-6131alain.brunet@mcgill.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 31, 2011

First Posted

May 6, 2011

Study Start

March 1, 2011

Primary Completion

January 1, 2015

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

CA(1)