Effect of Propranolol on Preventing Post-Traumatic Stress Disorder - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00158262

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 IV

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:

MedlinePlus related topics: Post-Traumatic Stress Disorder

Drug Information available for: Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment:	128
Study Start Date:	August 2004
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Propranolol	Drug: Propranolol long-acting 240 mg/day
Placebo Comparator: 2	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

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Roger K. Pitman, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Roger Pitman, MD, Harvard Medical School
ClinicalTrials.gov Identifier:	NCT00158262 History of Changes
Other Study ID Numbers:	R01 MH68603, DATR AD-TS
Study First Received:	September 7, 2005
Last Updated:	September 25, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

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 February 12, 2012