Status:
UNKNOWN
Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-67 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01221883
Start Date
May 1 2013
End Date
December 1 2014
Last Update
March 20 2013
Active Locations (1)
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1
Hadassah Medical Organitation
Jerusalem, Israel