Dexamethasone as an Immediate Intervention

Study Overview
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Brief Summary
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To determine if a single dose of dexamethasone (5 mg) administered in the first 12 hours following a potentially traumatic event alters a) cortisol and FKBP5 RNA the next day in the periphery measured in saliva; b) FKBP5 methylation by 1 month; c) executive functioning and emotion regulation functioning; d) psychophysiological (heart rate, respiration, skin conductance) in response cued reminders of the trauma; e) enhances the likelihood of remission of PTSD symptom severity.

Official Title
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Dexamethasone as an Immediate Intervention to Reduce Long-Term Stress Responses

Conditions
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Trauma

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18-70 years Evidence of acute Post Traumatic Event (PTE) exposure defined by Diagnostic and Statistical Manual criterion 'A' Evidence of a significant stress response defined by DSM V PTSD criterion 'B' and meeting at least criteria for 'partial PTSD' or a minimum of 3 of 4 DSM V PTSD symptom criterion Score of 60 or higher on the Subjective Units of Distress Scale (SUDS) Living in New York tri-state area Fluency in English, Spanish Exclusion Criteria: Admission to an intensive care unit or other overnight admission In the Emergency Department for more than 6 hours Evidence of ongoing traumatic exposure (e.g. domestic violence) Evidence of psychotic symptoms Evidence of homicidality/suicidality Adults with an open head injury, a positive CT scan, loss of consciousness >30 seconds or survivors in a coma Adults in police custody or Department of Correction (DOC) patients Inability to understand the study's procedures, risks, or side effects, or otherwise unable to give informed consent. Females who are nursing or pregnant (as confirmed by a positive urine pregnancy test). Permanent cardiac pacer implant. . Self-reported medical conditions that may be affected by DEX including asthma, epilepsy,diabetes, liver disease, kidney disease, thyroid disorder, muscle disorder, history of malaria,tuberculosis, osteoporosis, glaucoma or cataracts. Self-reported adverse reactions to steroids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br> | Drug: Dexamethasone<br>* After six (6) hours of the accident, subject will take 5 mg of DEX in the Emergency Department (ED). Within twenty-four (24) hours, the subjects will send in a saliva sample. After sexen (7) days, subjects will participate in a phone interview. After thirty (30) days, subjects will participate in an online assessment and return for a one month follow-up visit. Subjects will then participate in online assessments at months 3,6,9, and 12 months.<br>* Other names: DEX;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on PTSD symptom severity measured with the PTSD Check-List 5 (PCL-5) | Mean symptom severity on the PCL-5 will be compared between groups using an independent samples T-test. | 1 month, 3 months, 6 months, 9 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol Levels measured from saliva samples |  | 24 hours post ED departure | 
| Score on Subjective Units of Distress (SUDS) | Scale of 0 to 10 for measuring the subjective intensity of disturbance or distress currently experienced by an individual. The individual self assesses where they are on the scale. | 1 month, 3 months, 6 months, 9 months, and 12 months | 
| Score on the Kessler 6 Scale | Measure of Psychological distress in the anxiety-depression spectrum | 1 month, 3 months, 6 months, 9 months, and 12 months | 
| Score on Life Satisfaction Scale | The Satisfaction with Life Scale to assess satisfaction with people's lives as a whole. The scale does not assess satisfaction with specific life domains, such as health or finances, but allows subjects to integrate and weigh these domains in whatever way they choose. | 1 month, 3 months, 6 months, 9 months, and 12 months | 
| Score on Center for Epidemiologic Studies Depression Scale (CES-D) |  | 1 month, 3 months, 6 months, 9 months, and 12 months | 
| Score on Perceived Ability to Cope with Trauma Scale (PACT) |  | 1 month, 3 months, 6 months, 9 months, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD (Post Traumatic Stress Disorder), Emergency Department