Effectiveness of Propranolol For Treating People With Post-Traumatic Stress Disorder
Information source: Weill Medical College of Cornell University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Traumatic Stress Disorder
Intervention: Propanolol (Drug); Placebo (Drug); Cognitive therapy workbook (Behavioral)
Phase: Phase 4
Sponsored by: Weill Medical College of Cornell University
Official(s) and/or principal investigator(s):
Margaret Altemus, MD, Principal Investigator, Affiliation: Weill Medical College of Cornell University
This study will evaluate the effectiveness of propranolol in reducing symptoms of distress
in people with post-traumatic stress disorder.
Official title: Efficacy of Propanolol for Treatment of Posttraumatic Stress Disorder
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)
Beck Depression Inventory (BDI)
Post-traumatic Scale-Self Score (PS-SR)
Brief Symptoms Inventory-Short Form (BSI-SF)
Post-traumatic stress disorder (PTSD) is a common and disabling condition, with about 10% of
people having experienced PTSD at some point during their lives. The diagnosis of PTSD
requires certain criteria: exposure to a severe psychological trauma and the persistent
presence of three symptom clusters that include re-experiencing the traumatic event,
physiologic hyperarousal, and emotional numbing paired with avoidance of stimuli associated
with the event. Stimuli and cues associated with the trauma, such as features of an
assailant or accident site, can cause a person to re-experience the traumatic memory and
associated feelings of helplessness and fear. When re-experiencing a traumatic memory,
people with PTSD usually undergo a heightened stress-related hormonal response that further
solidifies new stimulating associations with the traumatic memory. Treatment with
propranolol, a blood pressure-lowering drug that reduces stress-related hormonal responses,
may be an effective means of preventing the formation of traumatic memories and of improving
PTSD symptoms. This study will evaluate the effectiveness of propranolol in reducing
symptoms of distress associated with traumatic memories in people with PTSD.
Participation in this study will last 14 weeks. All potential participants will undergo a
4-hour initial visit that will begin with a medical and psychiatric history review, a
psychiatric interview, and symptom questionnaires. Participants will then be assigned
randomly to take a test dose of either propranolol or placebo. Upon completion of the test
dose, participants will begin 14 weeks of treatment with their assigned test dose
medication. Participants will be asked to take the study medication each time they have a
traumatic memory associated with hyperarousal symptoms, but no more than two times a day.
Using a cognitive behavioral therapy based-workbook, participants will track their symptoms
daily and when they use cognitive techniques to relieve symptoms.
Participants will attend study visits every 2 weeks for the 14 weeks of treatment. During
these visits, participants will describe any side effects experienced, complete interviews
and questionnaires about PTSD symptom severity, review with study officials their daily
workbook entries, and pick up medication. Study participation will end upon completion of
the Week 14 study visit.
For information on a related study, please follow this link:
Minimum age: 18 Years.
Maximum age: 50 Years.
- DSM-IV diagnosis of PTSD or meets the five of the six diagnostic criteria for PTSD
(event, hyperarousal, re-experiencing, duration, and distress/impaired functioning
symptom criteria), but not the avoidance/numbing symptom criteria
- Past or current asthma
- Diabetes or heart disease
- Currently pregnant or breastfeeding
- Concurrent use of daily benzodiazepine; daily use of antidepressant medication
allowed if dose has been stable for the 3 months before study entry
- Exposure therapy or additional cognitive therapy during the course of the study
(supportive psychotherapy is allowed if ongoing for at least 3 months before study
- Substance abuse
- Current use of beta blockers, amiodarone, chlorpromazine, cimetidine, clonidine, or
Locations and Contacts
Weill Cornell Medical College, New York, New York 10065, United States
Starting date: December 2003
Last updated: June 27, 2012