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Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Pablo Roitman, Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE October 14, 2010
First Posted Date  ICMJE October 15, 2010
Last Update Posted Date March 20, 2013
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam
Official Title  ICMJE Early Pharmacological Intervention With Diazepam in the Emergency Room Setting to Prevent Posttraumatic Stress Disorder (PTSD).
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Posttraumatic Stress Disorder
Intervention  ICMJE Drug: Diazepam
Single dose 10mg Diazepam tablet
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo capsule in ER, identical follow up like those in the active arm.
    Intervention: Drug: Diazepam
  • Experimental: Diazepam
    10 mg of Diazepam mg orally at ER only (a single administration)
    Intervention: Drug: Diazepam
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 19, 2013)
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2010)
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Outpatients that have experienced an acute event that meets the DSM-IV A.1 PTSD criterion: "the person experienced, witnessed, or was confronted with an event or events that involved actual or threatened death or serious injury, or a threat to the physical integrity of self or others;"
  • Outpatients that also meet DSM-IV A.2. PTSD criterion: "the person's response involved intense fear, helplessness, or horror;" and
  • Outpatients that have a heart rate upon ED presentation >80 BPM
  • Outpatients that hadn't fallen asleep for a night after traumatic event before ED arrival;

Exclusion Criteria:

  • Physical injury that requires hospitalization, interferes with a patient's ability to cooperate with screening or give informed consent, or otherwise contraindicates participation;
  • Traumatic event reflecting ongoing victimization (e.g., domestic violence) to which the patient is likely to be re-exposed during the study period;
  • Head injury with loss of consciousness or amnesia;
  • Medical condition that contraindicates the administration of diazepam :

    • hepatic insufficiency, severe
    • hypersensitivity to diazepam
    • myasthenia gravis
    • narrow-angle glaucoma, acute
    • respiratory insufficiency, severe
    • sleep apnea syndrome
  • Current use of medication that may involve potentially dangerous interactions with diazepam, including opioids, barbitals and another benzodiazepines; when used in combination, these drugs have additive CNS and respiratory depressant effects
  • Women who are currently pregnant or nursing.
  • Those at immediate risk of harming self or others; those who have a clinically significant medical illness or other significant psychiatric illness;
  • Overt psychopathology, substance abuse/dependence, intoxication, odor of alcohol, or discernible substance effect;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 67 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01221883
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pablo Roitman, Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hadassah Medical Organization
Verification Date March 2013

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