Effect of Propranolol on Preventing Post-Traumatic Stress Disorder - Tabular View

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Effect of Propranolol on Preventing Post-Traumatic Stress Disorder

This study is ongoing, but not recruiting participants.

Study NCT00158262. Last updated on September 25, 2008. Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Effect of Propranolol on Preventing Post-Traumatic Stress Disorder

Official Title ^†

Prophylaxis of Post-Traumatic Stress Disorder With Post-Trauma Propranolol

Brief Summary

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.

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Post-Traumatic Stress Disorder

Intervention ^†

Drug: Propranolol
Drug: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

128

Start Date ^†

August 2004

Completion Date

May 2009

Eligibility 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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00158262

Organization ID

R01 MH68603

Secondary IDs ^††

DATR AD-TS

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Roger K. Pitman, MD

Massachusetts General Hospital

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

September 2008

First Received Date ^†

September 7, 2005

Last Updated Date

September 25, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.