Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pablo Roitman, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01221883
First received: October 14, 2010
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Posttraumatic Stress Disorder
Drug: Diazepam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Pharmacological Intervention With Diazepam in the Emergency Room Setting to Prevent Posttraumatic Stress Disorder (PTSD).

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Clinician Administered Posttraumatic Scale (CAPS) [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221883

Locations
Israel
Hadassah Medical Organitation
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Pablo Roitman, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01221883     History of Changes
Other Study ID Numbers: ER DIAZEPAM PTSD- HMO-CTIL
Study First Received: October 14, 2010
Last Updated: March 19, 2013
Health Authority: Ministry of Health - Director General Israel:

Keywords provided by Hadassah Medical Organization:
Posttraumatic Stress
Prevention
Diazepam

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Diazepam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anticonvulsants
Antiemetics
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
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014