TraumaPhase 1NCT02753166
Dexamethasone as an Immediate Intervention
A Phase 1 study testing Dexamethasone in people with Trauma, run by NYU Langone Health at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Trauma
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 12 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Medical Center
New York, New York, 10016
About this study
Official title: Dexamethasone as an Immediate Intervention to Reduce Long-Term Stress Responses
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.
- Conditions
- Trauma
- Being tested
- Dexamethasone
- Keywords
- PTSD (Post Traumatic Stress Disorder), Emergency Department
- Medical subject headings
- Wounds and Injuries, Combat Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called DEX
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month, 3 months, 6 months, 9 months, and 12 months
Secondary outcomes (6)
Cortisol Levels measured from saliva samples
Measured: 24 hours post ED departure
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.
Measured: 1 month, 3 months, 6 months, 9 months, and 12 months
Score on the Kessler 6 Scale
Measure of Psychological distress in the anxiety-depression spectrum
Measured: 1 month, 3 months, 6 months, 9 months, and 12 months
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.
Measured: 1 month, 3 months, 6 months, 9 months, and 12 months
Score on Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: 1 month, 3 months, 6 months, 9 months, and 12 months
Score on Perceived Ability to Cope with Trauma Scale (PACT)
Measured: 1 month, 3 months, 6 months, 9 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startJan 2017
- Primary completion12 Dec 2017
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Galatzer-Levy, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753166
- Sponsor's protocol ID
- 15-01318
- Status last verified
- Dec 2017
- First submitted
- 26 Apr 2016
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone as an Immediate Intervention to Reduce Long-Term Stress Responses
- ClinicalTrials.gov ID
- NCT02753166
- Acronym / sponsor ID
- 15-01318
- Conditions
- Trauma
- Keywords
- PTSD (Post Traumatic Stress Disorder), Emergency Department
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: DEXAfter 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. | Drug | Dexamethasone |
Primary outcome
Change in score on PTSD symptom severity measured with the PTSD Check-List 5 (PCL-5)
Time frame: 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.
6 secondary outcomes
Cortisol Levels measured from saliva samples
Time frame: 24 hours post ED departure
Score on Subjective Units of Distress (SUDS)
Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months
Score on the Kessler 6 Scale
Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months
Score on Life Satisfaction Scale
Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months
Score on Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months
Score on Perceived Ability to Cope with Trauma Scale (PACT)
Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac Galatzer-Levy, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone in people with Trauma, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score on PTSD symptom severity measured with the PTSD Check-List 5 (PCL-5) (time frame: 1 month, 3 months, 6 months, 9 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.