Dexamethasone as an Immediate Intervention

NYU Langone Health

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Trauma

Interventions

DexamethasoneDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

New York University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

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.