Prevention of Posttraumatic Stress Disorder (PTSD) With Early Hydrocortisone Treatment: Pilot
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Kent State University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kent State University
Collaborator:
Information provided by:
Kent State University
ClinicalTrials.gov Identifier:
NCT00597857
First received: January 10, 2008
Last updated: January 27, 2009
Last verified: January 2009
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Purpose
People experience a wide range of outcomes following a traumatic event. Although rates differ depending on type of trauma, 20-60% of trauma victims may develop posttraumatic stress disorder (PTSD). However, not all trauma victims develop PTSD. Previous research has found that trauma victims who develop PTSD excrete lower levels of urinary cortisol immediately after a trauma than victims who do not develop PTSD. Other research has suggested that increasing levels of cortisol may protect against the development of PTSD in patients such as yourself- but this has not yet been examined. Cortisol is a naturally occurring hormone in your body, and the present study is designed to test whether increasing cortisol levels can protect against or decrease symptoms of PTSD. Participants in this study will be randomly assigned to one of two treatment groups. Participants will receive either hydrocortisone (20mg, twice per day) or a placebo (a sugar pill) for 10 days with a six-day taper. There is an equal chance of being in either treatment group, and neither the participant nor the experimenters will know which treatment was received (except in case of an emergency).
| Condition | Intervention |
|---|---|
|
Posttraumatic Stress Disorder |
Drug: Hydrocortisone Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Prevention of PTSD With Early Hydrocortisone Treatment: Pilot |
Resource links provided by NLM:
Drug Information available for:
Hydrocortisone acetate
Hydrocortisone
Hydrocortisone sodium succinate
Hydrocortisone cypionate
Hydrocortisone butyrate
Hydrocortisone valerate
Hydrocortisone probutate
U.S. FDA Resources
Further study details as provided by Kent State University:
Primary Outcome Measures:
- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: one- and three-months post-trauma ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 65 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
receipt of a placebo pill for 16 days
|
Drug: placebo
receipt of a placebo pill for 16 days
|
|
Active Comparator: 2
oral pill of hydrocortisone (ranging from 20mg - 2.5mg) taken for 10 days with a taper for 6 days (based on Pitman et al, 2002).
|
Drug: Hydrocortisone
Participants will receive a tapering low-dose of hydrocortisone in pill form for 10 days, twice a day, after the trauma.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- involved in a traumatic event and admitted to the level 1 trauma center within 12 hours after the trauma
Exclusion Criteria:
- Glasgow coma scale score of less than 14 (at the time that you speak to patient)
- Amnestic for the events during and immediately following the traumatic event
- Unable to understand consent procedure or current substance abuse
- Traumatic event occurred more than 12 hours before initial medication dose can be given (i.e., patient life-flight or transferred after significant time has passed).
- Allergy to cortisol.
- Pregnant or breast-feeding
- Traumatic event of potentially ongoing nature that the participant is likely to be re-exposed to during the study (e.g. domestic violence)
- Presence of injuries (e.g. pelvic or lower extremity fractures) requiring readmission for surgery 1-2 weeks later once swelling has diminished. Patients requiring such delayed operative procedures will be excluded.
- Presence of medical condition that contraindicates the administration of cortisol, including (but not necessarily limited to) peptic ulcers, Cushing's disease, hypothyroidism, current alcoholism or cirrhosis, hepatitis, diverticulitis, nonspecific ulcerative colitis, myasthenia gravis, seizure disorders, renal insufficiency, disorders of immunosuppression, current viral or bacterial infection, diabetes mellitus, history of myocardial infarction, or recipient of solid organ or bone marrow transplant.
- On a current corticosteroid regimen (inhaled, oral, or injection). This may include patients with asthma, multiple sclerosis, arthritis, allergic conditions, optic neuritis, or tuberculosis
- Corticosteroid use in the previous 6 months
- Current use of medications that may have potentially dangerous interactions with cortisol including other corticosteroids, any immunosuppressant medications, drugs affecting hepatic microsomal enzymes, cyclosporine, and anticholinesterase agents.
- Injuries requiring treatment with steroids (e.g., suspected spinal cord injury, cerebral edema).
- Patients must be able to take oral medications within 12 hours post-trauma.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597857
Contacts
| Contact: Douglas L Delahanty, PhD | (330) 672-2395 | ddelahan@kent.edu |
Locations
| United States, Ohio | |
| Akron City Hospital | Recruiting |
| Akron,, Ohio, United States, 44309 | |
| Contact: William Wallon, MD 330-971-1721 FallonW@summa-health.org | |
| Sub-Investigator: William Fallon, MD | |
Sponsors and Collaborators
Kent State University
Investigators
| Principal Investigator: | Doulas L Delahanty, PhD | Kent State University |
More Information
Publications:
Delahanty, D.L., Royer, D.K., Spoonster, E., & Raimonde, A.J. (2003). Peritraumatic dissociation is inversely related to catecholamine levels in initial urine samples of motor vehicle accident victims. Journal of Trauma and Dissociation, 4, 65-80.
| Responsible Party: | Douglas L. Delahanty, PhD, Kent State University |
| ClinicalTrials.gov Identifier: | NCT00597857 History of Changes |
| Other Study ID Numbers: | 05-025, R34MH073014 |
| Study First Received: | January 10, 2008 |
| Last Updated: | January 27, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Cortisol succinate Hydrocortisone acetate Hydrocortisone 17-butyrate 21-propionate |
Hydrocortisone Hydrocortisone-17-butyrate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Dermatologic Agents |
ClinicalTrials.gov processed this record on May 21, 2013