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

Phase 4

Terminated

Conditions: Post-Traumatic Stress Disorder

Interventions: Drug: Propanolol
Drug: Placebo
Behavioral: Cognitive therapy workbook

Registration Number: NCT00648375

Lead Sponsor: Weill Medical College of Cornell University

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.

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

http://clinicaltrials.gov/show/NCT00391430

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propranolol	Propanolol	Participants will take propranolol for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day.
Propranolol	Cognitive therapy workbook	Participants will take propranolol for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day.
Placebo	Cognitive therapy workbook	Participants will take placebo for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day.
Placebo	Placebo	Participants will take placebo for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day.

Primary Outcome Measures

Name	Time	Method
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)	Measured at Week 0, 2,4,6,8,10,12,14	Scores range from 0-70, higher scores represent more severe symptoms

Secondary Outcome Measures

Name	Time	Method
Change in Post-traumatic Scale-Self Score (PS-SR)	Measured at Weeks 0,2,4,6,8,10,12, 14	This is a 17-item self-report scale. Scores range from 0-51, higher scores represent more severe symptoms.
Change in Brief Symptoms Inventory-Short Form (BSI-SF)	Measured at Weeks 0,2,4,6,8,10,12, 14	BSI-SF is an 18 item scale used for a global score of general distress. Scores range from 0-72, higher scores represent more severe symptoms
Change in Depression Measured by Beck Depression Inventory (BDI)	Measured at Weeks 0,2,4,6,8,10,12, 14	Scores range from 0-30, higher scores represent more severe symptoms