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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

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: Diazepam Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Diazepam

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsule in ER, identical follow up like those in the active arm.
Drug: Diazepam
Single dose 10mg Diazepam tablet

Experimental: Diazepam
10 mg of Diazepam mg orally at ER only (a single administration)
Drug: Diazepam
Single dose 10mg Diazepam tablet

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

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 identifier (NCT number): NCT01221883

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Hadassah Medical Organitation
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
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Responsible Party: Pablo Roitman, MD, Hadassah Medical Organization Identifier: NCT01221883    
First Posted: October 15, 2010    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013
Keywords provided by Pablo Roitman, Hadassah Medical Organization:
Posttraumatic Stress
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Adjuvants, Anesthesia
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action