Dexamethasone as an Immediate Intervention
- Registration Number
- NCT02753166
- Lead Sponsor
- NYU Langone Health
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexamethasone Dexamethasone -
- Primary Outcome Measures
Name Time Method Change in score on PTSD symptom severity measured with the PTSD Check-List 5 (PCL-5) 1 month, 3 months, 6 months, 9 months, and 12 months Mean symptom severity on the PCL-5 will be compared between groups using an independent samples T-test.
- Secondary Outcome Measures
Name Time Method Cortisol Levels measured from saliva samples 24 hours post ED departure 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 Score on Subjective Units of Distress (SUDS) 1 month, 3 months, 6 months, 9 months, and 12 months 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.
Score on the Kessler 6 Scale 1 month, 3 months, 6 months, 9 months, and 12 months Measure of Psychological distress in the anxiety-depression spectrum
Score on Life Satisfaction Scale 1 month, 3 months, 6 months, 9 months, and 12 months 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.
Trial Locations
- Locations (1)
New York University Medical Center
🇺🇸New York, New York, United States