Propranolol for the Treatment of Acute Stress Disorder
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|ClinicalTrials.gov Identifier: NCT00069355|
Recruitment Status : Completed
First Posted : September 24, 2003
Last Update Posted : March 4, 2008
|First Submitted Date ICMJE||September 23, 2003|
|First Posted Date ICMJE||September 24, 2003|
|Last Update Posted Date||March 4, 2008|
|Study Start Date ICMJE||September 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00069355 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Propranolol for the Treatment of Acute Stress Disorder|
|Official Title ICMJE||Propranolol For the Treatment of Acute Stress Disorder|
This 10-week study will examine whether propranolol, a medication that blocks the activity of the stress hormones adrenaline and noradrenaline, can relieve acute stress disorder (ASD) and symptoms from persisting long-term. ASD is a condition that some people develop soon after exposure to trauma. They may be anxious, depressed, have trouble sleeping, startle easily, have difficulties concentrating, and feel as though the event is happening again. Propranolol has been used for many years to treat high blood pressure and heart disease, and has been found useful in treating anxiety states such as social phobia and migraine.
Men and women between 18 and 65 years of age who were recently exposed to trauma (between 1 and 3 weeks of evaluation in this study) may be eligible for this study. Candidates must be diagnosed with ASD and must have been mentally healthy before the traumatic event. They will be screened for the study with a medical and psychiatric interview, physical examination, electrocardiogram (EKG), and blood and urine tests.
Participants will be evaluated with the following procedures:
After the evaluation, participants are randomly assigned to receive either propranolol or placebo (a look-alike pill with no active ingredient) for 8 weeks During this time they are seen by a doctor once a week for 4 weeks and then once every other week for the rest of the study. At the end of the 8-week treatment period, participants undergo the same evaluation they had before beginning treatment (see above). The decision to continue treatment will then be decided based on the individual's clinical condition and whether he or she received propranolol or placebo.
The effects of exposure to severe stress differ between individuals. Still, a typical response pattern consisting of increased anxiety and arousal, sleep difficulties, preoccupation with and re-experiencing of the traumatic event is the rule. In most trauma survivors the severity of this condition diminishes within days or weeks. Still, in some cases psychopathology persists, and can lead to severe and chronic PTSD. The diagnosis of "Acute Stress Disorder" (ASD) was introduced in DSM-IV, addressing psychopathology between 2 days and 1 month of exposure to trauma. It has been shown that 60%-80% of patients who meet criteria for ASD will go on and suffer from PTSD. Nevertheless, pharmacological trials in PTSD have only been performed, with few exceptions, in chronic populations. Chronic PTSD has emerged as a treatment resistant condition, with only partial response to treatment with antidepressant and anxiolytic agents. Therefore, the potential benefits of early treatment intervention in this condition could be immeasurable.
A principal model proposed to explain the initiation and perpetuation of PTSD is the fear-conditioning model. It assumes that intrusive, involuntary, repetitive, vivid emotionally laden memories of the trauma are pivotal to the development of the disorder. Although such memories are a part of the early trauma response, in healthy trauma survivors these memories gradually lose their intrusive quality and much of their emotional charge, allowing recovery. In PTSD this process does not occur. The impediment to recovery may result from deeper encoding and consolidation of the traumatic memories inhibiting the normal process of extinction that is part of the healthy processing of the traumatic event.
Animal and human research has conclusively shown that emotionally charged stimulation is remembered better than less emotionally arousing information. Animal and human data show that catecholamines, particularly norepinephrine, augment consolidation of emotional memory. Furthermore, administration of catecholamine receptor blockers cancels the enhanced memory for emotional, compared to non-emotional, information. These data suggest that administration of catecholamine receptor blockers soon after trauma may obstruct consolidation of emotional memories, thereby preventing or alleviating posttraumatic symptomatology. Treatment experience in humans is limited to the administration of propranolol in single case descriptions and a pilot prevention study that was not sufficiently powered to allow a definite inference. However, the overall impression from administration of propranolol in the early time period after trauma is positive. In light of the neurophysiology and preliminary data presented above, we propose a prospective, randomized placebo controlled study of propranolol treatment in ASD.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Stress Disorders, Traumatic, Acute|
|Intervention ICMJE||Drug: Propranolol|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||October 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||Child, Adult, Older Adult|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00069355|
|Other Study ID Numbers ICMJE||030296
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||October 2004|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP