Dexamethasone as an Immediate Intervention

NYU Langone Health

Status and phase

Withdrawn

Phase 1

Conditions

Trauma

Treatments

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT02753166

15-01318

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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