Dexamethasone as an Immediate Intervention

• Status: Withdrawn
• Trial end date: 2017-12-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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