Effect of Propranolol on Preventing Post-Traumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roger K. Pitman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00158262
First received: September 7, 2005
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

This study will assess the effectiveness of taking propranolol soon after a traumatizing incident in reducing the incidence and severity of post-traumatic stress disorder in acutely traumatized individuals.


Condition Intervention Phase
Post-Traumatic Stress Disorder
Drug: Propranolol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Prophylaxis of Post-Traumatic Stress Disorder With Post-Trauma Propranolol

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Psychophysiologic responses to traumatic recollection [ Time Frame: Measured at Months 1 and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post Traumatic Stress Disorder symptoms [ Time Frame: Measured at Months 1 and 3 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: August 2004
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Propranolol. For more information, refer to the published article: Hoge EA, Worthington JJ, Nagurney JT, Chang Y, Kay EB, Feterowski CM, Katzman AR, Goetz JM, Rosasco ML, Lasko NB, Zusman RM, Pollack MH, Orr SP, Pitman RK. Effect of acute posttrauma propranolol on PTSD outcome and physiological responses during script-driven imagery. CNS Neuroscience and Therapeutics; 2012;18:21-27
Drug: Propranolol
long-acting 240 mg/day
Other Name: Inderal
Placebo Comparator: 2
Placebo. For more information, refer to the published article: Hoge EA, Worthington JJ, Nagurney JT, Chang Y, Kay EB, Feterowski CM, Katzman AR, Goetz JM, Rosasco ML, Lasko NB, Zusman RM, Pollack MH, Orr SP, Pitman RK. Effect of acute posttrauma propranolol on PTSD outcome and physiological responses during script-driven imagery. CNS Neuroscience and Therapeutics; 2012;18:21-27
Drug: Placebo
Placebo

Detailed Description:

Post-Traumatic Stress Disorder (PTSD) is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. This study will assess the effect of post-trauma propranolol on reducing the incidence and severity of PTSD. The study will also evaluate propranolol's effectiveness as a preventive measure against subsequent PTSD symptoms.

Participants in this double-blind study will be recruited upon admission to the Massachusetts General Hospital Emergency Department after exposure to a psychologically traumatic event. Baseline psychometric and psychobiologic measurements will be collected. Within 6 hours following the traumatic event, participants will be randomly assigned to receive either 40 mg of short-acting propranolol or placebo and 60 mg of either long-acting propranolol or placebo. For the next 10 days, participants will receive 120 mg of either long-acting propranolol or placebo twice daily. A 9-day medication tapering will follow. Participants will undergo psychophysiologic, psychodiagnostic, and psychometric testing for PTSD 1 and 3 months following the traumatic event.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Experienced an acute psychological traumatic event
  • Heart rate of 80 bpm or greater
  • Understands English

Exclusion Criteria:

  • Traumatic event that occurred more than four hours before arrival to emergency department
  • Physical injury that may affect safe participation (e.g., head injury)
  • Systolic blood pressure less than 100 mm Hg
  • Medical or surgical condition that poses a risk of shock
  • Medical condition that may affect the safe administration of propranolol
  • Previous adverse reaction to, or non-compliance with, a B-blocker
  • Current use of medication that may react badly with propranolol
  • Elevated saliva alcohol level
  • Presence of salivary opiates, marijuana, cocaine, or amphetamines
  • Pregnant or breastfeeding
  • Traumatic event reflecting ongoing victimization
  • Psychiatric condition that may affect safe participation
  • Unwilling or unable to commute to Boston for research visits
  • Attending physician in emergency department does not advise participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158262

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Roger K. Pitman, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Roger K. Pitman, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00158262     History of Changes
Other Study ID Numbers: R01 MH68603, R01MH068603
Study First Received: September 7, 2005
Last Updated: April 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Post-Traumatic Stress Disorder
Prevention
Propranolol
Psychophysiology

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on July 28, 2014