Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam
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|ClinicalTrials.gov Identifier: NCT01221883|
Recruitment Status : Unknown
Verified March 2013 by Pablo Roitman, Hadassah Medical Organization.
Recruitment status was: Active, not recruiting
First Posted : October 15, 2010
Last Update Posted : March 20, 2013
PTSD is a pervasive and frequent disorder. Early psychological treatment - but not pharmacology - effectively prevent PTSD.
Current pharmacological studies did not include treatment given immediately after trauma exposure.
However, a recent study of opiates suggests that their early administration may reduce the likelihood of developing PTSD - possibly by mitigating early post-traumatic distress (UCR) - within an adequate window of time.
Benzodiazepines are often used to reduce anxiety and agitation during stressful situations - including traumatic event.
These compounds may increase the likelihood of developing PTSD when administered few days after the traumatic event - but their effect as an immediate intervention has not been studied - despite their frequent and uninformed use at this stage.
This work will evaluate the effect of diazepam - a BZ compound - on PTSD symptom trajectory following traumatic event in a randomized controlled design.
Following the studies of opiates it is hoped that diazepam, administered within hours of the traumatic event, and before the first night sleep (a memory consolidating condition) will reduce the likelihood of developing PTSD. However, an adverse effect cannot be excluded, and thus the investigators posit a bidirectional hypothesis.
The importance of this work is that it will provide the necessary evidence to sanction a frequently practiced use of benzodiazepines.
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Drug: Diazepam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Early Pharmacological Intervention With Diazepam in the Emergency Room Setting to Prevent Posttraumatic Stress Disorder (PTSD).|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||December 2014|
Placebo Comparator: Placebo
Placebo capsule in ER, identical follow up like those in the active arm.
Single dose 10mg Diazepam tablet
10 mg of Diazepam mg orally at ER only (a single administration)
Single dose 10mg Diazepam tablet
- Clinician Administered Posttraumatic Scale (CAPS) [ Time Frame: 20 minutes ]Is a structured clinical interview that evaluates the 17 DSM-IV PTSD and associated symptoms on dimensions of frequency and intensity (0-4 scale for each). The CAPS also includes measures of global response validity, global PTSD symptom severity, and impact of symptoms on occupational and global functioning. The CAPS contains explicit, behaviorally anchored prompt questions and rating scale descriptors to enhance reliability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221883
|Hadassah Medical Organitation|