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Effectiveness of Propranolol For Treating People With Post-Traumatic Stress Disorder

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title † Effectiveness of Propranolol For Treating People With Post-Traumatic Stress Disorder
Official Title † Efficacy of Propanolol for Treatment of Posttraumatic Stress Disorder
Brief Summary

This study will evaluate the effectiveness of propranolol in reducing symptoms of distress in people with post-traumatic stress disorder.
Detailed Description

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.
Study Phase Phase IV
Study Type † Interventional
Study Design † Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure † Clinician Administered PTSD Scale for DSM-IV (CAPS-DX) [ Time Frame: Measured at Week 14 ] [ Designated as safety issue: No ]
Secondary Outcome Measure † Beck Depression Inventory (BDI) [ Time Frame: Measured at Week 14 ] [ Designated as safety issue: No ]
Post-traumatic Scale-Self Score (PS-SR) [ Time Frame: Measured at Week 14 ] [ Designated as safety issue: No ]
Brief Symptoms Inventory-Short Form (BSI-SF) [ Time Frame: Measured at Week 14 ] [ Designated as safety issue: No ]
Condition † Post-Traumatic Stress Disorder
Intervention † Drug: Propanolol
Drug: Placebo
Behavioral: Cognitive therapy workbook
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 40
Start Date † December 2003
Completion Date September 2009
Eligibility Criteria †

Inclusion Criteria:

  • 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

Exclusion 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 entry)
  • Substance abuse
  • Current use of beta blockers, amiodarone, chlorpromazine, cimetidine, clonidine, or digoxin
Gender Both
Ages 18 Years to 50 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Diane Engel, LMSW     212-746-3759     die2001@med.cornell.edu    
Contact: Theresa Nguyen, NP     212-746-4850     mtn9001@med.cornell.edu    
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00648375
Organization ID 5 P50 MH58911-01
Secondary IDs †† 0305006139
Study Sponsor † National Institute of Mental Health (NIMH)
Collaborators ††
Investigators †
Principal Investigator:     Margaret Altemus, MD     Weill Cornell Medical College    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date August 2008
First Received Date † March 28, 2008
Last Updated Date August 19, 2008

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

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