Prevention of Posttraumatic Stress Disorder (PTSD) With Diazepam

NCT01221883 | Unknown Phase 4

• 1 other identifier: ER DIAZEPAM PTSD- HMO-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress; Prevention; Diazepam

Outcome Measures

Primary Outcomes (1)

• 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.

  20 minutes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsule in ER, identical follow up like those in the active arm.

Drug: Diazepam

Diazepam

EXPERIMENTAL

10 mg of Diazepam mg orally at ER only (a single administration)

Drug: Diazepam

Interventions

Diazepam DRUG

Single dose 10mg Diazepam tablet

Diazepam; Placebo

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organitation

Jerusalem, Israel

Location

Related Publications (2)

• 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.

  PMID: 9746445 BACKGROUND

• 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.

  PMID: 17064443 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Diazepam

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 15, 2010
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

IL (1)