Back to resultsPrevention of Posttraumatic Stress Disorder (PTSD) With Diazepam
Primary Purpose
Posttraumatic Stress Disorder
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Diazepam
Sponsored by
About this trial
This is an interventional prevention trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress, Prevention, Diazepam
Eligibility 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;
Sites / Locations
- Hadassah Medical Organitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Diazepam
Arm Description
Placebo capsule in ER, identical follow up like those in the active arm.
10 mg of Diazepam mg orally at ER only (a single administration)
Outcomes
Primary Outcome Measures
Clinician Administered Posttraumatic Scale (CAPS)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01221883
First Posted
October 14, 2010
Last Updated
March 19, 2013
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01221883
Brief Title
Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam
Official Title
Early Pharmacological Intervention With Diazepam in the Emergency Room Setting to Prevent Posttraumatic Stress Disorder (PTSD).
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress, Prevention, Diazepam
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule in ER, identical follow up like those in the active arm.
Arm Title
Diazepam
Arm Type
Experimental
Arm Description
10 mg of Diazepam mg orally at ER only (a single administration)
Intervention Type
Drug
Intervention Name(s)
Diazepam
Intervention Description
Single dose 10mg Diazepam tablet
Primary Outcome Measure Information:
Title
Clinician Administered Posttraumatic Scale (CAPS)
Description
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.
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Facility Information:
Facility Name
Hadassah Medical Organitation
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
9746445
Citation
Gelpin E, Bonne O, Peri T, Brandes D, Shalev AY. Treatment of recent trauma survivors with benzodiazepines: a prospective study. J Clin Psychiatry. 1996 Sep;57(9):390-4.
Results Reference
background
PubMed Identifier
17064443
Citation
Meares S, Shores EA, Batchelor J, Baguley IJ, Chapman J, Gurka J, Marosszeky JE. The relationship of psychological and cognitive factors and opioids in the development of the postconcussion syndrome in general trauma patients with mild traumatic brain injury. J Int Neuropsychol Soc. 2006 Nov;12(6):792-801. doi: 10.1017/S1355617706060978.
Results Reference
background
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Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam
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