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

This study has been terminated.
(inadequate recruitment)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Margaret Altemus, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00648375
First received: March 28, 2008
Last updated: June 27, 2012
Last verified: June 2012

March 28, 2008
June 27, 2012
December 2003
June 2009   (final data collection date for primary outcome measure)
Clinician Administered PTSD Scale for DSM-IV (CAPS-DX) [ Time Frame: Measured at Week 14 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00648375 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Propranolol For Treating People With Post-Traumatic Stress Disorder
Efficacy of Propanolol for Treatment of Posttraumatic Stress Disorder

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

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:

http://clinicaltrials.gov/show/NCT00391430

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
  • Drug: Propanolol
    Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
    Other Name: Inderal
  • Drug: Placebo
    Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
  • Behavioral: Cognitive therapy workbook
    Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
  • Experimental: A
    Participants will take propranolol for 14 weeks.
    Interventions:
    • Drug: Propanolol
    • Behavioral: Cognitive therapy workbook
  • Placebo Comparator: B
    Participants will take placebo for 14 weeks.
    Interventions:
    • Drug: Placebo
    • Behavioral: Cognitive therapy workbook
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
September 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00648375
P50 MH058911-01, P50MH058911-01, 0305006139
No
Margaret Altemus, Weill Medical College of Cornell University
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Principal Investigator: Margaret Altemus, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP