Recruiting
Phase 2

Propranolol

Sponsor:

Douglas Mental Health University Institute

Code:

NCT01349439

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Propranolol

Short acting + long acting propranolol + memory reactivation

Study Details

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.

Conditions

Posttraumatic Stress Disorder

Study ID

NCT01349439

Start date

Mar, 2011

Status verified date

Jun, 2014

Primary completion date

Jan, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Propranolol + Memory Reactivation

This arm involves recalling the traumatic event after administration of propranolol

experimental: Placebo + Memory reactivation

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

experimental: Placebo + No Memory Reactivation

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

experimental: Propranolol + No Memory Reactivation

This arm involves administration of propranolol without recalling the traumatic event

other: Open-label Propranolol + Memory Reactivation

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.

Interventions

Propranolol

1mg per Kg (participant weight)

Short acting + long acting propranolol + memory reactivation

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.

Primary outcome measure

  • Electromyogram [ Time Frame: Two weeks post-treatment ]
  • Heart rate [ Time Frame: Two weeks post-treatment ]
  • Skin conductance [ Time Frame: Two weeks post-treatment ]

Central Contacts and Locations

Central contacts

Alain R Brunet, Ph.D.

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

Locations

Douglas Mental Health University Institute

Recruiting

Verdun, Quebec, Canada, H4H 1R3

Contacts

Andrea Ashbaugh, Ph.D.

514-761-6131andrea.ashbaugh@douglas.mcgill.ca

Principal Investigator:

Alain Brunet, Ph.D.

More Information

Sponsor

Douglas Mental Health University Institute

Last update posted

Jun 24, 2014

Last verified

Jun, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Douglas Mental Health University Institute on 2014-06-24.