Phase 4 N=43 Randomized Double-blind Prevention

Effect of Propranolol on Preventing Posttraumatic Stress Disorder

Post-Traumatic Stress Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00158262 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Physiological Posterior Probability of Posttraumatic Stress Disorder (PTSD) as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 1 — 40.7; 33.7 percent probability

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Propranolol (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Physiological Posterior Probability of Posttraumatic Stress Disorder (PTSD) as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 1	40.7; 33.7	—
PRIMARY Physiological Posterior Probability of PTSD as Determined From Psychophysiologic Responses During Script-Driven Mental Imagery at Month 3	34.9; 32.0	—
SECONDARY Clinician-Administered PTSD Scale (CAPS) Total Score	28.5; 28.5; 19.0; 21.2	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Experienced an acute psychological traumatic event
Heart rate of 80 beats per minute (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 beta-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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00158262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.