Clinical Trial: Effect of Propranolol on Preventing Post-Traumatic Stress Disorder

This study is currently recruiting patients.
Verified by National Institute of Mental Health (NIMH) September 2005

Sponsored by: 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 propanolol soon after a traumatizing incident in reducing the incidence and severity of post-traumatic stress disorder in acutely traumatized individuals.
Condition Intervention Phase
Stress Disorders, Post Traumatic
 Drug: Propranolol
Phase IV

MedlinePlus related topics:  Post-Traumatic Stress Disorder

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Prophylaxis of Post-Traumatic Stress Disorder with Post-Trauma Propranolol

Further Study Details: 
Primary Outcomes: Psychophysiologic responses to traumatic recollection, Months 1 and 3
Secondary Outcomes: Post Traumatic Stress Disorder symptoms, Months 1 and 3
Expected Total Enrollment:  128

Study start: August 2004

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 propanolol on reducing the incidence and severity of PTSD. The study will also evaluate propanolol’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 propanolol or placebo and 60 mg of either long-acting propanolol or placebo. For the next 10 days, participants will receive 120 mg of either long-acting propanolol 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   -   55 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00158262

Roger K. Pitman, MD      617-726-5333    roger_pitman@hms.harvard.edu

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
Roger K. Pitman, MD  617-726-5333    roger_pitman@hms.harvard.edu 
Mark Pollack, MD,  Sub-Investigator
Randall M Zusman, MD,  Sub-Investigator
Scott P Orr, PhD,  Sub-Investigator
Natasha Lasko, PhD,  Sub-Investigator
Yuchiao Chang, PhD,  Sub-Investigator
Roger K Pitman, MD,  Principal Investigator
Glen Saxe, MD,  Sub-Investigator

      Brigham and Women''''s Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
Roger K. Pitman, MD  617-726-5333    roger_pitman@hms.harvard.edu 
Thomas Stair, MD,  Sub-Investigator

Study chairs or principal investigators

Roger K. Pitman, MD,  Principal Investigator,  Massachusetts General Hospital   

More Information

Study ID Numbers:  1 R01 MH068603-1A1
Last Updated:  September 10, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00158262
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13

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