Effect of Propranolol on Preventing Posttraumatic Stress Disorder

Phase 4 Completed 43 enrolled Massachusetts General Hospital National Institute of Mental Health (NIMH) · collab

RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start: 2004-09
Primary completion: 2008-05
Completion: 2008-05

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Propranolol; Mean Difference (Final Values) 7.0 (95% CI -2.7 to 16.7) NCT00158262 ↗

registry analysis (superiority test); Placebo vs Propranolol; Mean Difference (Final Values) 2.9 (95% CI -4.8 to 10.7) NCT00158262 ↗

Publications

Results Hoge EA, Worthington JJ, Nagurney JT, Chang Y, Kay EB, Feterowski CM, Katzman AR, Goetz JM, Rosasco ML, Lasko NB, Zusman RM, Pollack MH, Orr SP, Pitman RK. Effect of acute posttrauma propranolol on PTSD outcome and physiological responses during script-driven imagery. CNS Neurosci Ther. 2012 Jan;18(1):21-7. doi: 10.1111/j.1755-5949.2010.00227.x. Epub 2011 Jan 10.
Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Propranolol	Small molecule	120 mg	Oral