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
  Purpose

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


Condition Intervention Phase
Post-Traumatic Stress Disorder
Drug: Propanolol
Drug: Placebo
Behavioral: Cognitive therapy workbook
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Propanolol for Treatment of Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale for DSM-IV (CAPS-DX) [ Time Frame: Measured at Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: December 2003
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Participants will take propranolol for 14 weeks.
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
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.
Placebo Comparator: B
Participants will take placebo for 14 weeks.
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.

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.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00391430

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648375

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Margaret Altemus, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Margaret Altemus, Associate Professor, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00648375     History of Changes
Other Study ID Numbers: P50 MH058911-01, P50MH058911-01, 0305006139
Study First Received: March 28, 2008
Last Updated: June 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
Propanolol
Beta Blockers
Reconsolidation
Cognitive Therapy
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 11, 2014