Dexamethasone as an Immediate Intervention

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02753166
• Other study ID #: 15-01318
• Status: Withdrawn
• Phase: Phase 1
• First received: April 26, 2016
• Last updated: December 12, 2017
• Start date: January 2017
• Est. completion date: December 12, 2017

Study information

• Verified date: December 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 12, 2017
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma

Intervention

Drug:
• Dexamethasone
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.

Locations

Country	Name	City	State
United States	New York University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cortisol Levels measured from saliva samples		24 hours post ED departure
Secondary	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
Secondary	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
Secondary	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
Secondary	Score on Center for Epidemiologic Studies Depression Scale (CES-D)		1 month, 3 months, 6 months, 9 months, and 12 months
Secondary	Score on Perceived Ability to Cope with Trauma Scale (PACT)		1 month, 3 months, 6 months, 9 months, and 12 months