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Effect of Propranolol on Preventing Post-Traumatic Stress Disorder
This study is ongoing, but not recruiting participants.
Study NCT00158262   Information provided by National Institute of Mental Health (NIMH)
First Received: September 7, 2005   Last Updated: September 25, 2008   History of Changes

September 7, 2005
September 25, 2008
August 2004
May 2009   (final data collection date for primary outcome measure)
Psychophysiologic responses to traumatic recollection [ Time Frame: Measured at Months 1 and 3 ] [ Designated as safety issue: No ]
Psychophysiologic responses to traumatic recollection, Months 1 and 3
Complete list of historical versions of study NCT00158262 on ClinicalTrials.gov Archive Site
Post Traumatic Stress Disorder symptoms [ Time Frame: Measured at Months 1 and 3 ] [ Designated as safety issue: No ]
Post Traumatic Stress Disorder symptoms, Months 1 and 3
 
Effect of Propranolol on Preventing Post-Traumatic Stress Disorder
Prophylaxis of Post-Traumatic Stress Disorder With Post-Trauma Propranolol

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.

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.

Phase IV
Interventional
Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Post-Traumatic Stress Disorder
  • Drug: Propranolol
  • Drug: Placebo
Experimental: Propranolol
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
128
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00158262
Roger Pitman, MD, Harvard Medical School
R01 MH68603, DATR AD-TS
National Institute of Mental Health (NIMH)
 
Principal Investigator: Roger K. Pitman, MD Massachusetts General Hospital
National Institute of Mental Health (NIMH)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP